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Monoclonal Antibodies

Nipocalimab + Certolizumab for Rheumatoid Arthritis (DAISY Trial)

Phase 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline
If has received prior anti-TNF agent (including biosimilars), has demonstrated IR to >=1 anti-TNF agent (including biosimilars), as assessed by the treating physician:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 30
Awards & highlights

DAISY Trial Summary

This trial looks at if a drug combo works better than one drug alone to treat an illness.

Who is the study for?
This trial is for adults with moderate to severe active rheumatoid arthritis (RA) who have not responded well to certain RA medications. Participants must have a specific number of swollen and tender joints, test positive for RA markers like ACPA or RF, and have elevated CRP levels. They should not have heart failure, recent heart attacks or strokes, demyelinating diseases, immunodeficiency unrelated to RA treatment, or be asplenic.Check my eligibility
What is being tested?
The study tests if combining Nipocalimab with Certolizumab is more effective than using Certolizumab alone in treating RA. Patients will either receive both drugs or just Certolizumab along with a placebo to compare the outcomes.See study design
What are the potential side effects?
Potential side effects may include injection site reactions, increased risk of infections due to immune system suppression by the drugs, allergic reactions, headaches, nausea and possibly others that are common with medications targeting the immune system.

DAISY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have active rheumatoid arthritis with at least 6 swollen and 6 tender joints.
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I have not responded to at least one anti-TNF treatment as determined by my doctor.
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I have been on etanercept, adalimumab, or golimumab for at least 12 weeks.

DAISY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Secondary outcome measures
Change From Baseline in Clinical Disease Activity Index Score (CDAI) at Week 12
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Number of Participants With Adverse Events of Special interests (AESIs)
+9 more

DAISY Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Certolizumab + NipocalimabExperimental Treatment2 Interventions
Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
Group II: Certolizumab + PlaceboActive Control2 Interventions
Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~420
Certolizumab
2014
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,223 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
722 Patients Enrolled for Rheumatoid Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,820 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
322 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial recruiting patients aged 45 and over?

"In accordance with the stated requirements, this trial is open to participants ranging from 18 years old to 75."

Answered by AI

Does my health profile qualify me to be involved in the experiment?

"All potential patients for this research must have a diagnosis of rheumatoid arthritis and be between 18 - 75 years old. The trial is seeking to recruit approximately 85 individuals in total."

Answered by AI

Has the combination of Certolizumab and Nipocalimab been authorized by the Food and Drug Administration?

"Based on available Phase 2 data, the safety of Certolizumab + Nipocalimab was assigned a score of two since there is some evidence confirming its protection yet no supporting its efficacy."

Answered by AI

What is the upper limit of participants for this clinical trial?

"Affirmative. According to the clinicaltrials.gov database, this research study is presently enrolling individuals for participation. The trial was first made available on August 15th 2023 and underwent revisions as recently as September 1st of the same year. A total of 85 participants will be accepted between 3 different locations."

Answered by AI

Are there vacancies available for potential participants in this trial?

"Indeed, the records located on clinicaltrials.gov demonstrate that this medical experiment is still enlisting enrollees. It was inaugurated on August 15th 2023 and last modified on September 1st of the same year. 85 individuals are being admitted at 3 distinct sites."

Answered by AI

Who else is applying?

What site did they apply to?
Arizona Arthritis and Rheumatology Research, PLLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
2023. "A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028438.
All > Rheumatoid Arthritis > Ra
~33 spots leftby Sep 2024
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