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Vaccine
COVID-19 Booster Vaccines for Autoimmune Diseases
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
multiple sclerosis (MS), or pemphigus
Individuals 18 years of age or older that meet classification criteria for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), rheumatoid arthritis (RA), multiple sclerosis (MS), or pemphigus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to receipt of covid-19 vaccine doses) and weeks 4, 12, 24, 36, and 48 status post receipt of covid-19 vaccine booster dose
Awards & highlights
Study Summary
This trial is testing different additional doses of COVID-19 vaccine in people with autoimmune diseases who didn't have a strong response to their initial vaccine.
Who is the study for?
Adults and children with autoimmune diseases like lupus, arthritis, MS, or pemphigus who had a weak response to previous COVID-19 vaccines can join. They must be on certain immune-suppressing meds and not have active infections or recent severe vaccine reactions.Check my eligibility
What is being tested?
The trial is testing different booster shots of COVID-19 vaccines in people with autoimmune diseases taking immune system medications. It's checking which boosters help the most when the first vaccine doses didn't work well enough.See study design
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at the injection site, tiredness, headache, muscle pain, chills, fever, nausea. Rarely there might be allergic reactions or heart inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple sclerosis or pemphigus.
Select...
I am 18 or older with lupus, scleroderma, RA, MS, or pemphigus.
Select...
I am currently on MMF, MPA, MTX, or B cell depleting agents like rituximab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (prior to receipt of covid-19 vaccine doses) and weeks 4, 12, 24, 36, and 48 status post receipt of covid-19 vaccine booster dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to receipt of covid-19 vaccine doses) and weeks 4, 12, 24, 36, and 48 status post receipt of covid-19 vaccine booster dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of adult and pediatric participants who have a protective antibody response at Week 4
Secondary outcome measures
Change in anti-COVID-19 antibody response
Change in anti-SARS-CoV-2 neutralizing antibody levels
Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Clinical Global Impression of Change (CGI-C)
+26 moreTrial Design
43Treatment groups
Experimental Treatment
Group I: Cohort F, Arm F4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction
Group II: Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)Experimental Treatment3 Interventions
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Group III: Cohort F, Arm F2P: Moderna mRNA-1273, Bivalent + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group IV: Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)Experimental Treatment5 Interventions
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Group V: Cohort F, Arm F1P: BNT162b2, Bivalent + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Group VI: Cohort F, Arm F1: Ad26.COV2.S + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Group VII: Cohort E, Arm E4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MTX)Experimental Treatment2 Interventions
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
Group VIII: Cohort E, Arm E3: Moderna mRNA-1273 + Withhold IS (MTX)Experimental Treatment3 Interventions
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Group IX: Cohort E, Arm E2P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group X: Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)Experimental Treatment5 Interventions
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Group XI: Cohort E, Arm E1P: BNT162b2, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Group XII: Cohort E, Arm E1: Ad26.COV2.S + Withhold IS (MTX)Experimental Treatment2 Interventions
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Group XIII: Cohort D, Arm D4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
Group XIV: Cohort D, Arm D3: Moderna mRNA-1273 + Withhold IS (MMF or MPA)Experimental Treatment3 Interventions
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Group XV: Cohort D, Arm D2P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group XVI: Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)Experimental Treatment5 Interventions
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Group XVII: Cohort D, Arm D1P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Group XVIII: Cohort D, Arm D1: Ad26.COV2.S + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Group XIX: Cohort C, Arm C3: Ad26.COV2.S + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions
Arm closed, effective protocol version 3.0. Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XX: Cohort C, Arm C2P: BNT162b2, Bivalent + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXI: Cohort C, Arm C2: BNT162b2 + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXII: Cohort C, Arm C1P: Moderna mRNA-1273, Bivalent + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXIII: Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXIV: Cohort B, Arm B6: Ad26.COV2.S + Withhold IS (MTX)Experimental Treatment2 Interventions
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
Group XXV: Cohort B, Arm B5P: BNT162b2, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
Group XXVI: Cohort B, Arm B5: BNT162b2 + Withhold IS (MTX)Experimental Treatment2 Interventions
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
Group XXVII: Cohort B, Arm B4P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group XXVIII: Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)Experimental Treatment2 Interventions
Adult Participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group XXIX: Cohort B, Arm B3: Ad26.COV2.S + Continue IS (MTX)Experimental Treatment2 Interventions
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXX: Cohort B, Arm B2P: BNT162b2, Bivalent + Continue IS (MTX)Experimental Treatment2 Interventions
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXXI: Cohort B, Arm B2: BNT162b2 + Continue IS (MTX)Experimental Treatment2 Interventions
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXXII: Cohort B, Arm B1P: Moderna mRNA-1273, Bivalent + Continue IS (MTX)Experimental Treatment2 Interventions
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXXIII: Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)Experimental Treatment2 Interventions
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XXXIV: Cohort A, Arm A6: Ad26.COV2.S + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
Group XXXV: Cohort A, Arm A5P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Group XXXVI: Cohort A, Arm A5: BNT162b2 + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Group XXXVII: Cohort A, Arm A4P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group XXXVIII: Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Group XXXIX: Cohort A, Arm A3: Ad26.COV2.S + Continue IS (MMF or MPA)Experimental Treatment2 Interventions
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XL: Cohort A, Arm A2P: BNT162b2, Bivalent + Continue IS (MMF or MPA)Experimental Treatment2 Interventions
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XLI: Cohort A, Arm A2: BNT162b2 + Continue IS (MMF or MPA)Experimental Treatment2 Interventions
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XLII: Cohort A, Arm A1P: Moderna mRNA-1273, Bivalent + Continue IS (MMF or MPA)Experimental Treatment2 Interventions
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Group XLIII: Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)Experimental Treatment2 Interventions
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Withhold IS (MMF or MPA)
2021
Completed Phase 2
~260
Monovalent [B.1.351] CoV2 preS dTM-AS03
2021
Completed Phase 2
~260
Moderna mRNA-1273, Bivalent
2021
Completed Phase 2
~260
Continue IS (MMF or MPA)
2021
Completed Phase 2
~260
BNT162b2
2021
Completed Phase 4
~91740
Continue IS (MTX)
2021
Completed Phase 2
~260
Withhold IS (B cell depletion therapy)
2021
Completed Phase 2
~260
Ad26.COV2.S
2021
Completed Phase 3
~84050
BNT162b2, Bivalent
2021
Completed Phase 2
~260
Withhold IS (MTX)
2021
Completed Phase 2
~260
Continue IS (B cell depletion therapy)
2021
Completed Phase 2
~260
Moderna mRNA-1273
2021
Completed Phase 2
~260
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,212 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
4,037 Patients Enrolled for Multiple Sclerosis
Autoimmunity Centers of ExcellenceOTHER
22 Previous Clinical Trials
1,147 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
158 Patients Enrolled for Multiple Sclerosis
Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,352 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
331 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have common variable immunodeficiency and/or am on immune globulin replacement therapy.You didn't have a good response to the first COVID-19 vaccine you received.I received both Janssen and mRNA COVID-19 vaccines before Stage 2 Screening.You didn't have a strong enough response to a previous COVID-19 vaccine.I have received an extra COVID-19 vaccine dose before the second stage of screening.I am 18 or older with lupus, scleroderma, RA, MS, or pemphigus.I have received a COVID-19 vaccine booster.I have multiple sclerosis or pemphigus.To be eligible to participate in the study, you must meet all of the criteria below:I am currently being treated with cyclophosphamide.My condition prevents me from continuing with my current immunosuppressive therapy.I have not received a live vaccine in the last 2 months and do not plan to during the study.You have a chronic infection that is currently active.I have an active infection and took antibiotics in the last 14 days.I am on dialysis or have had an organ transplant.I have had heart inflammation within 6 weeks after a COVID-19 vaccine dose.I am starting or currently receiving chemotherapy or immunotherapy for cancer.You had a bad allergic reaction to the COVID-19 vaccine or any of its ingredients.I am currently on MMF, MPA, MTX, or B cell depleting agents like rituximab.I have recently had or currently have COVID-19.You have used another experimental drug or treatment within a certain period before the screening for this study.I am currently taking MMF/MPA and MTX medications.Your hemoglobin level is less than 8.0 grams per deciliter.I am a woman planning to become pregnant during the trial.People who are in prison or held against their will for mental or physical health treatment.I have not received any COVID-19 antibodies or plasma products in the last 30 days.I completed my COVID-19 vaccination between 4 and 52 weeks ago for Stage 1, or within 48 weeks for Stage 2.I haven't been in a clinical trial for BCDT within the last 18 months, or if I was, I received an anti-CD20 or CD19 drug.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A, Arm A2: BNT162b2 + Continue IS (MMF or MPA)
- Group 2: Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
- Group 3: Cohort D, Arm D1P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)
- Group 4: Cohort B, Arm B5: BNT162b2 + Withhold IS (MTX)
- Group 5: Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)
- Group 6: Cohort B, Arm B1P: Moderna mRNA-1273, Bivalent + Continue IS (MTX)
- Group 7: Cohort C, Arm C1P: Moderna mRNA-1273, Bivalent + Continue IS (B cell depletion therapy)
- Group 8: Cohort C, Arm C2P: BNT162b2, Bivalent + Continue IS (B cell depletion therapy)
- Group 9: Cohort D, Arm D2P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)
- Group 10: Cohort A, Arm A5P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)
- Group 11: Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
- Group 12: Cohort B, Arm B6: Ad26.COV2.S + Withhold IS (MTX)
- Group 13: Cohort B, Arm B5P: BNT162b2, Bivalent + Withhold IS (MTX)
- Group 14: Cohort B, Arm B2: BNT162b2 + Continue IS (MTX)
- Group 15: Cohort D, Arm D4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MMF or MPA)
- Group 16: Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)
- Group 17: Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
- Group 18: Cohort A, Arm A4P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)
- Group 19: Cohort B, Arm B4P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)
- Group 20: Cohort A, Arm A2P: BNT162b2, Bivalent + Continue IS (MMF or MPA)
- Group 21: Cohort B, Arm B2P: BNT162b2, Bivalent + Continue IS (MTX)
- Group 22: Cohort A, Arm A3: Ad26.COV2.S + Continue IS (MMF or MPA)
- Group 23: Cohort B, Arm B3: Ad26.COV2.S + Continue IS (MTX)
- Group 24: Cohort C, Arm C3: Ad26.COV2.S + Continue IS (B cell depletion therapy)
- Group 25: Cohort E, Arm E1: Ad26.COV2.S + Withhold IS (MTX)
- Group 26: Cohort F, Arm F1: Ad26.COV2.S + Withhold IS (B cell depletion therapy)
- Group 27: Cohort A, Arm A6: Ad26.COV2.S + Withhold IS (MMF or MPA)
- Group 28: Cohort E, Arm E1P: BNT162b2, Bivalent + Withhold IS (MTX)
- Group 29: Cohort A, Arm A5: BNT162b2 + Withhold IS (MMF or MPA)
- Group 30: Cohort C, Arm C2: BNT162b2 + Continue IS (B cell depletion therapy)
- Group 31: Cohort D, Arm D1: Ad26.COV2.S + Withhold IS (MMF or MPA)
- Group 32: Cohort D, Arm D3: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
- Group 33: Cohort E, Arm E4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MTX)
- Group 34: Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)
- Group 35: Cohort E, Arm E3: Moderna mRNA-1273 + Withhold IS (MTX)
- Group 36: Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)
- Group 37: Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)
- Group 38: Cohort F, Arm F4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (B cell depletion therapy)
- Group 39: Cohort A, Arm A1P: Moderna mRNA-1273, Bivalent + Continue IS (MMF or MPA)
- Group 40: Cohort E, Arm E2P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)
- Group 41: Cohort F, Arm F2P: Moderna mRNA-1273, Bivalent + Withhold IS (B cell depletion therapy)
- Group 42: Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
- Group 43: Cohort F, Arm F1P: BNT162b2, Bivalent + Withhold IS (B cell depletion therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05000216 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many Canadian sites are hosting this clinical trial?
"30 different medical centres across the United States are participating in this trial. Major cities such as Atlanta, Philadelphia, and Cleveland have a presence amongst other more local clinics. To reduce travel demands it is advised to pick the facility closest to you if one decides to join."
Answered by AI
Has the FDA sanctioned using IS (MMF or MPA) as a medical treatment?
"Our internal rating system for safety reflects that IS (MMF or MPA) is a 2 on the scale of 1-3. This score is based upon the fact that this Phase 2 trial has some evidence indicating its security, but none yet confirming efficacy."
Answered by AI
What is the primary goal of this medical experiment?
"The aim of this trial, to be assessed over a 4 week period following vaccine booster dose administration, is to determine the proportion of adults and children who develop protective antibodies in response. Additionally, secondary objectives include assessing the rate at which participants are infected with SARS-CoV-2 (Sever Acute Respiratory Syndrome Coronavirus) as well as any changes in disease activity using Patient Reported Outcome Measurement Information System (PROMIS-29) self report assessments. Lastly, PROMIS will also be utilized on pediatric patients to measure Child Onset Lupus Erythematosus Global Flare severity."
Answered by AI
How has IS (MMF or MPA) been studied in the past?
"At present, there are 389 ongoing clinical studies pertaining to IS (MMF or MPA), with 98 in the final stage of research. Of these trials, the majority is centred around Nellore, AP. However, a total of 10100 medical centres are conducting clinical trials for IS (MMF or MPA)."
Answered by AI
Which medical condition is IS (MMF or MPA) typically prescribed to address?
"Intravenous use of either mycophenalate mofetil (MMF) or mycophenolate sodium (MPA) is often prescribed to treat small cell lung cancer, active pauciarticular juvenile rheumatoid arthritis, head and neck carcinoma, and multiple sclerosis."
Answered by AI
What is the scope of participants in this clinical trial?
"The trial sponsor, Rho Federal Systems Division, Inc., is looking for 2340 participants that match the inclusion criteria. The study will be implemented across multiple sites, such as Benaroya Research Institute at Virginia Mason: Internal Medicine in Atlanta and Emory University School of Medicine: Division of Rheumatology in Philadelphia."
Answered by AI
Are any openings available for research participants in this investigation?
"The clinical trial is presently calling for volunteers. Information posted on the clinicaltrials.gov website displays that this study was initially announced on August 13th 2021, and recently updated to reflect changes made as of November 22nd 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
Ohio
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
New York University Langone Medical Center: Department of Medicine, Division of Rheumatology
Nationwide Children's Hopspital
University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
Because of my general pain, experience. I want to do any clinical trials to help with the de development of cures and just help find out how clinical trials further help investigate to help those of us that are sick.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics: < 24 hours
- The Emory Clinic: Division of Rheumatology: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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