A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)

UCB

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Certolizumab Pegol + Methotrexate (MTX); Biological: Placebo + Methotrexate (MTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521923

2011-001729-25 (EudraCT Number)

RA0055 Period 2

Details and patient eligibility

About

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Exclusion criteria

• Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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359 participants in 3 patient groups, including a placebo group

CZP 200 mg Q2W + Methotrexate

Experimental group

Treatment:

Biological: Certolizumab Pegol + Methotrexate (MTX)

CZP 200 mg Q4W + Methotrexate

Experimental group

Treatment:

Biological: Certolizumab Pegol + Methotrexate (MTX)

Placebo + Methotrexate

Placebo Comparator group

Treatment:

Biological: Placebo + Methotrexate (MTX)