A Phase 2a Multicenter, Randomized, Double Blind, Parallel-group, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Subjects with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504045-31-00

Acronym

80202125ARA2002

Enrollment

Registered

2023-10-09

Start date

2024-02-08

Completion date

2024-10-29

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

Change from baseline in DAS28-CRP at Week 12

Interventions

DRUGFOLIC ACID

DRUGMETHOTREXATE

DRUGSULFASALAZINE

DRUG-

DRUGCHLOROQUINE

DRUGHYDROXYCHLOROQUINE

DRUGCALCIUM FOLINATE

DRUGPARACETAMOL

DRUGCimzia 200 mg solution for injection in pre-filled syringe

DRUGSaline

DRUG0.9% Sodium Chloride Solution for Injection

DRUGLEFLUNOMIDE

DRUGJNJ-80202135

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in DAS28-CRP at Week 12	—

Countries

Germany, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026