← Back to Search

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
Awards & highlights

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
Select...
I have active rheumatoid arthritis with at least 6 swollen and 6 tender joints.
Select...
I have not responded to at least one anti-TNF treatment as determined by my doctor.
Select...
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:
Select...
I have a history of diseases like multiple sclerosis.
Select...
I have or might have an immune system problem not caused by my RA treatment, and no family history of immune issues.
Select...
I have been diagnosed with congestive heart failure but it's under control and I don't have symptoms.
Select...
I do not have a functioning spleen.

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

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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,556 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
722 Patients Enrolled for Rheumatoid Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,356 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
322 Patients Enrolled for Rheumatoid Arthritis
~0 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top