Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Certolizumab Pegol (CZP) — BIOLOGICAL
  * Active substance: an injectable volume of 1 ml solution for injection CZP * Pharmaceutical form: prefilled syringes CZP * Concentration: 200 mg/ml CZP * Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.
• Adalimumab (ADA) — BIOLOGICAL
  * Active substance: an injectable volume of 0.8 ml solution for injection ADA * Pharmaceutical form: prefilled syringes ADA * Concentration: 40 mg/0.8 ml ADA * Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.
• Methotrexate (MTX) — DRUG
  * Active substance: Methotrexate * Pharmaceutical form: oral tablet * Concentration: 15-25 mg/week * Route of Administration: MTX orally

Study Details

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Key Dates

Start date

Dec 31, 2011

Status verified

Jul 2017

Primary completion

Nov 30, 2015

Completion

Jan 31, 2016

Study Design

Enrollment

915 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Certolizumab Pegol + Methotrexate (CZP + MTX)
• Active Comparator: Adalimumab + Methotrexate (ADA + MTX)
• Active Comparator: CZP + MTX followed by ADA + MTX
  Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12.
• Active Comparator: ADA + MTX followed by CZP + MTX
  Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.

Primary Outcome Measure

Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12 [ Time Frame: Week 12 ]

Locations (62)

Find similar trials in Birmingham, AL

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