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Monoclonal Antibodies

Nipocalimab + Certolizumab for Rheumatoid Arthritis (DAISY Trial)

Phase 2

Waitlist Available

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:

Must not have

Has a history of known demyelinating disease such as multiple sclerosis or optic neuritis

Has a confirmed or suspected clinical immunodeficiency syndrome not related to treatment of RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 30

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of diseases like multiple sclerosis.

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I have or might have an immune system problem not caused by my RA treatment, and no family history of immune issues.

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I have been diagnosed with congestive heart failure but it's under control and I don't have symptoms.

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I do not have a functioning spleen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 30

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12

Secondary study objectives

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

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