IS (MMF or MPA) for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Benaroya Research Institute at Virginia Mason: Rheumatic Diseases, Seattle, WA
Rheumatoid Arthritis+17 More
IS (MMF or MPA) - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine booster dose might improve immune response to a COVID-19 vaccine in people with autoimmune disease.

See full description

Eligible Conditions

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus (SLE)
  • Pemphigus Vulgaris (PV)
  • Pediatric SLE
  • Juvenile Dermatomyositis (JDM)
  • Multiple Sclerosis
  • Systemic; Sclerosis, Progressive
  • Juvenile Idiopathic Arthritis (JIA)
  • Pediatric-Onset Multiple Sclerosis (POMS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether IS (MMF or MPA) will improve 2 primary outcomes and 40 secondary outcomes in patients with Rheumatoid Arthritis. Measurement will happen over the course of Through Day 7 post study vaccination.

Week 4
Change in anti-COVID-19 antibody response
Change in anti-SARS-CoV-2 neutralizing antibody levels
Change in disease activity in participant subset with Systemic Lupus Erythematosus (SLE) as measured by Thanou modified SELENA-SLEDAI Flare Index for Systemic Lupus Erythematosus (SLE)
Percentage of Subset Participants Who Seroconverted
Week 4
Change in disease activity as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Change in disease activity as measured by the Physician's Global Assessment
Change in disease activity in participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS
Change in disease activity in participant subset with Pemphigus as measured by Disease Area Index (PDAI) for Pemphigus
Change in disease activity in participant subset with Rheumatoid Arthritis (RA) as measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Change in disease activity in participant subset with Systemic Lupus Erythematosus (SLE) as measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Change in disease activity in participant subset with Systemic Sclerosis (SSc) as measured by Disease Flare Activity
Week 4
Fold increase in anti-COVID-19 antibody levels at Week 4, following participant receipt of a booster dose of COVID-19 vaccine
Week 4
Change in disease activity in adult participant subset with Systemic Lupus Erythematosus (SLE) as measured by Thanou modified SELENA-SLEDAI Flare Index for Systemic Lupus Erythematosus (SLE)
Week 4
Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Physician's Global Assessment
Change in disease activity as measured by the Patient Global Assessment
Change in disease activity as measured by the Patient Global Impression of Change (PGI-C)
Change in disease activity in adult participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS
Change in disease activity in adult participant subset with Pemphigus as measured by Disease Area Index (PDAI) for Pemphigus
Change in disease activity in adult participant subset with Rheumatoid Arthritis (RA) as measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Change in disease activity in adult participant subset with Systemic Lupus Erythematosus (SLE) as measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Change in disease activity in adult participant subset with Systemic Sclerosis (SSc) as measured by Disease Flare Activity
Change in disease activity in adult participants as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Change in disease activity in pediatric participant subset with JDM as measured by JDM Disease Activity Score (DAS)
Change in disease activity in pediatric participant subset with JIA as measured by Psoriasis Area and Severity Index (PASI) for psoriatic arthritis
Change in disease activity in pediatric participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS (POMS)
Change in disease activity in pediatric participant subset with POMS as measured by childhood-onset SLE Criteria for Global Flare
Change in disease activity in pediatric participant subset with juvenile dermatomyositis (JDM) as measured by Childhood Mysositis Assessment Scale
Change in disease activity in pediatric participant subset with juvenile idiopathic arthritis (JIA) as measured by JADAS10
Change in disease activity in pediatric participant subset with pediatric-onset multiple sclerosis (POMS) as measured by SLEDAI-2K
Change in disease activity in pediatric participants as measured by the Pediatric Quality of Life Inventory (PedsQL)
Day 28
Proportion of participants who experience any unsolicited Grade 1 or higher adverse events related to additional doses of the COVID-19 vaccine
Proportion of participants who experience any unsolicited Grade 1 or higher adverse events related to the COVID-19 vaccine booster
Day 7
Proportion of participants who experience any solicited Grade 1 or higher adverse events related to additional doses of the COVID-19 vaccine
Proportion of participants who experience any solicited Grade 1 or higher adverse events related to the COVID-19 vaccine booster
Week 48
Proportion of participants who experience any New Onset Chronic Medical Conditions (NOCMCs)
Proportion of participants who experience any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection
Proportion of participants who experience any medically attended adverse events (MAAEs)
Proportion of participants who experience any serious adverse events (SAEs)
Week 4
Proportion of adult and pediatric participants who have a protective antibody response at Week 4
Week 4
Proportion of participants who have a protective antibody response at Week 4
Week 4
Change in disease activity after receipt of COVID-19 vaccine booster as measured by the Clinical Global Impression of Change (CGI-C)
Week 4
Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Clinical Global Impression of Change (CGI-C)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

24 Treatment Groups

Cohort A, Arm A1: Moderna mRNA-1273 +IS (MMF or MPA)
1 of 24
Cohort F, Arm F3: Ad26.COV2.S + IS (B cell depletion therapy) + Moderna mRNA-127...
1 of 24
Cohort A, Arm A4: Moderna mRNA-1273
1 of 24
Cohort E, Arm E3: Ad26.COV2.S + IS (MTX) + Moderna mRNA-1273
1 of 24
Cohort A, Arm A5: BNT162b2
1 of 24
Cohort A, Arm A6: Ad26.COV2.S
1 of 24
Cohort B, Arm B4: Moderna mRNA-1273
1 of 24
Cohort C, Arm C3: Ad26.COV2.S +IS (B cell depletion therapy)
1 of 24
Cohort D, Arm D3: Ad26.COV2.S + IS (MMF or MPA) + Moderna mRNA-1273
1 of 24
Cohort B, Arm B2: BNT162b2 + IS (MTX)
1 of 24
Cohort D, Arm D2: mRNA Vaccine + IS (MMF or MPA) + Alternative mRNA Vaccine
1 of 24
Cohort B, Arm B3: Ad26.COV2.S + IS (MTX)
1 of 24
Cohort B, Arm B6: Ad26.COV2.S
1 of 24
Cohort A, Arm A3: Ad26.COV2.S + IS (MMF or MPA)
1 of 24
Cohort C, Arm C2: BNT162b2+IS (B cell depletion therapy)
1 of 24
Cohort B, Arm B1: Moderna mRNA-1273 + IS (MTX)
1 of 24
Cohort B, Arm B5: BNT162b2
1 of 24
Cohort D, Arm D1: mRNA Vaccine + IS (MMF or MPA) + Ad26.COV2.S
1 of 24
Cohort A, Arm A2: BNT162b2 +IS (MMF or MPA)
1 of 24
Cohort E, Arm E1: mRNA Vaccine + IS (MTX) + Ad26.COV2.S
1 of 24
Cohort E, Arm E2: mRNA Vaccine + IS (MTX) + Alternative mRNA Vaccine
1 of 24
Cohort F, Arm F1: mRNA Vaccine + IS (B cell depletion therapy) + Ad26.COV2.S
1 of 24
Cohort F, Arm F2: mRNA Vaccine + IS (B cell depletion therapy) + Alternative mRN...
1 of 24
Cohort C, Arm C1: Moderna mRNA-1273 +IS (B cell depletion therapy)
1 of 24
Experimental Treatment

This trial requires 2340 total participants across 24 different treatment groups

This trial involves 24 different treatments. IS (MMF Or MPA) is the primary treatment being studied. Participants will be divided into 24 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort A, Arm A1: Moderna mRNA-1273 +IS (MMF or MPA)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.
Cohort F, Arm F3: Ad26.COV2.S + IS (B cell depletion therapy) + Moderna mRNA-1273Participants 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 withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Cohort A, Arm A4: Moderna mRNA-1273
Biological
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.
Cohort E, Arm E3: Ad26.COV2.S + IS (MTX) + Moderna mRNA-1273Participants 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.
Cohort A, Arm A5: BNT162b2
Biological
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.
Cohort A, Arm A6: Ad26.COV2.S
Biological
Arm closed, effective protocol version 3.0. 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.
Cohort B, Arm B4: Moderna mRNA-1273
Biological
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.
Cohort C, Arm C3: Ad26.COV2.S +IS (B cell depletion therapy)Arm closed, effective protocol version 3.0. 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.
Cohort D, Arm D3: Ad26.COV2.S + IS (MMF or MPA) + Moderna mRNA-1273Participants 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.
Cohort B, Arm B2: BNT162b2 + IS (MTX)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.
Cohort D, Arm D2: mRNA Vaccine + IS (MMF or MPA) + Alternative mRNA VaccineParticipants 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.
Cohort B, Arm B3: Ad26.COV2.S + IS (MTX)Arm closed, effective protocol version 3.0. 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.
Cohort B, Arm B6: Ad26.COV2.S
Biological
Arm closed, effective protocol version 3.0. 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.
Cohort A, Arm A3: Ad26.COV2.S + IS (MMF or MPA)Arm closed, effective protocol version 3.0. 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.
Cohort C, Arm C2: BNT162b2+IS (B cell depletion therapy)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.
Cohort B, Arm B1: Moderna mRNA-1273 + IS (MTX)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.
Cohort B, Arm B5: BNT162b2
Biological
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.
Cohort D, Arm D1: mRNA Vaccine + IS (MMF or MPA) + Ad26.COV2.SParticipants 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.
Cohort A, Arm A2: BNT162b2 +IS (MMF or MPA)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.
Cohort E, Arm E1: mRNA Vaccine + IS (MTX) + Ad26.COV2.SParticipants 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.
Cohort E, Arm E2: mRNA Vaccine + IS (MTX) + Alternative mRNA VaccineParticipants 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.
Cohort F, Arm F1: mRNA Vaccine + IS (B cell depletion therapy) + Ad26.COV2.SParticipants 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 withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Cohort F, Arm F2: mRNA Vaccine + IS (B cell depletion therapy) + Alternative mRNA VaccineParticipants 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 MT,, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction.
Cohort C, Arm C1: Moderna mRNA-1273 +IS (B cell depletion therapy)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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Janssen COVID-19 Vaccine
FDA approved
Moderna COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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 for reporting.

Closest Location

Benaroya Research Institute at Virginia Mason: Rheumatic Diseases - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
systemic lupus erythematosus (SLE)
systemic sclerosis (SSc)
the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) or the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria (SLICC) classification criteria for SLE
the 2017 McDonald criteria for MS,
multiple sclerosis (MS), or pemphigus
the 2010 ACR/EULAR classification criteria for RA
the international consensus criteria for pemphigus
Individuals who meet all the following criteria are eligible for enrollment as study participants-
the 2013 EULAR/ACR classification criteria for SSc
rheumatoid arthritis (RA)

Patient Q&A Section

What causes pemphigus?

"The exact cause of pemphigus is unknown. However, many theories of the disease exist. The most favored is a reaction in the skin caused when the body responds to trauma (e.g. infection or autoantibody), possibly through an immunological mechanism. The symptoms of blistering have been observed in some of the diseased patients even when the direct stimuli are absent (e.g. in the case of paraneoplastic pemphigus). A direct antigenic stimulation or indirect mechanism (e.g. by a hypersensitization reaction of the skin to other proteins of the body) might, in some cases, be responsible for the disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pemphigus?

"Antibiotic medications are rarely used to prevent infection in patients with pemphigus vulgaris. In pemphigus foliaceus, anti-IL-12 therapy is a mainstay of treatment, because of its effectiveness in preventing blistering lesions recurrence due to IL-12 overproduction by macrophages." - Anonymous Online Contributor

Unverified Answer

Can pemphigus be cured?

"Skin lesions can be maintained on prednisone and doxycycline. However, in refractory cases, alternatives need to be explored and more research and clinical findings should follow." - Anonymous Online Contributor

Unverified Answer

What are the signs of pemphigus?

"The signs of pemphigus are a main clinical guide in the differential diagnosis. One should be vigilant to recognize subtle clues, particularly the presence of epidermal lesions that may be seen by dermatologists, but also consider whether the patient has blistering of the mouth and or genital area or if itching occurs, which is more often associated with pemphigus foliaceus than with bullous pemphigoid. The symptoms are summarized in Table 2." - Anonymous Online Contributor

Unverified Answer

How many people get pemphigus a year in the United States?

"The incidence of pemphigus has increased in the past 10 years according to these data. However, the increase has leveled off from an average annual increase of 17.5%. The reason for this stabilization of incidence is still unknown but the increase in average annual pemphigus incidence was probably caused by increasing use of immunosuppressive therapy for autoimmune diseases. The clinical manifestations of pemphigus, especially after adjusting for the use of immunosuppressive therapy, have not changed in this time." - Anonymous Online Contributor

Unverified Answer

What is pemphigus?

"Pemphigus is a blistering autoimmune diseases characterized by immunoglobulin autoantibodies against desmogleins that cause intraepidermal autoantibodies and intraepidermal IgG4 deposits. Clinically, the disease is characterized by blistering of the skin, mucous membranes, and mucosal structures in those areas of the body that are exposed to the environment. Pemphigus disease is not curable, and treatment consists of long-term follow up and medications to control symptoms. Pemphigus is rare. More than 100 million people currently suffer from one of at least seven different types of this rare disease. It is most common and serious in people of middle age." - Anonymous Online Contributor

Unverified Answer

What is the latest research for pemphigus?

"The study of pemphigus aims to analyze how it evolves (its clinical, immunopathological, and epidemiological profile, and its susceptibility) and to identify the environmental factors that could influence this kind of skin disease. In addition, studies on a genetic basis and of autoimmune and hypersensitivity mechanisms are being pursued in order to better understand the physiopathology of the disease and to give support to the management." - Anonymous Online Contributor

Unverified Answer

What does is (mmf or mpa) usually treat?

"A common misconception about the value of the MpA is that 1 mA is used to treat very small pustules on the skin that heal quickly and do not form scars. In reality, most of the people who would use a 1.5 mmb (1 mA) device would be patients with the skin disease pemphigus. The 1.5 mmb device would provide one tenth of the healing power of a 1.0 mmb electrode. In patients with pemphigus, a doctor or a nurse at first-time application of a 1.0 mmb electrodes helps to stabilize the treatment and to choose the right medication regimen, [Powerpoint lecture]." - Anonymous Online Contributor

Unverified Answer

Does pemphigus run in families?

"Although the inheritance pattern of familial pemphigus is not yet fully understood, it is suggested that this genetic phenomenon should be taken into account in future studies." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of is (mmf or mpa)?

"Is is used in small doses (mean 0.005% of body weight) in cosmetics for the treatment of acne, psoriasis, seborrhea, and hirsutism. Is is also used for the treatment of certain autoimmune skin conditions and oral lichen planus. However, side effects from higher doses or repeated use may occur. People who are taking immunosuppressants, especially ciclosporin (Neoral) and tacrolimus (Prograf), or people with a history of autoimmune disease should not use is. Is is not indicated for use on the skin." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of pemphigus?

"All people experiencing one of the main types of pemphigus are at risk of developing skin cancer. While the exact cause of pemphigus remains unknown, a number of potential risk factors have been identified, including: tobacco, alcohol, family history of skin cancer, exposure to sunlight, and previous skin injury. Doctors also recommend a complete skin examination of people with pemphigus, including a skin biopsy when this is necessary, to look for indicators of skin cancer, which might include squamous cell, cutaneous basal-cell or melanoma, as well as a thorough history of any other skin cancers detected during the exam." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in is (mmf or mpa) for therapeutic use?

"The most recent literature in the field has been published within the last 3 years. The use of intralesional and intravenous immunoglobulin, and other plasma products, should be evaluated for the treatment of all clinical forms of pemphigus. Additionally, prospective long-term randomized studies are needed to determine whether the newer preparations confer a definite long-term advantage over the existing therapies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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