Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CDP6038 — BIOLOGICAL
  60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
• CDP6038 — BIOLOGICAL
  120 mg sc at Weeks 0, 2, 4 6, 8, and 10
• CDP6038 — BIOLOGICAL
  240 mg sc at Weeks 0, 2, 4 6, 8, and 10
• Tocilizumab (Actemra or RoActemra) — BIOLOGICAL
  8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
• CDP6038 — BIOLOGICAL
  60 mg sc at Weeks 0, 4 and 8
• CDP6038 — BIOLOGICAL
  240 mg sc at Weeks 0, 4 and 8
• CDP6038 — BIOLOGICAL
  120 mg sc at Weeks 0, 4 and 8
• Placebo sc — OTHER
  0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
• Placebo sc — OTHER
  0.9% Sodium chloride for injection at Weeks 2, 6 and 10
• Placebo iv — OTHER
  0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Study Details

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.

Key Dates

Start date

Nov 30, 2010

Status verified

Jul 2024

Primary completion

Jun 30, 2012

Completion

Jun 30, 2012

Study Design

Enrollment

221 participants (actual)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: CDP6038 60 mg sc every 2 weeks plus methotrexate
• Experimental: CDP6038 60 mg sc every 4 weeks plus methotrexate
• Experimental: CDP6038 120 mg sc every 2 weeks plus methotrexate
• Experimental: CDP6038 120 mg sc every 4 weeks plus methotrexate
• Experimental: CDP6038 240 mg sc every 2 weeks plus methotrexate
• Experimental: CDP6038 240 mg sc every 4 weeks plus methotrexate
• Active Comparator: Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate
• Placebo Comparator: Placebo sc every 2 weeks plus methotrexate
• Placebo Comparator: Placebo sc every 4 weeks plus methotrexate

Primary Outcome Measure

Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo [ Time Frame: Baseline, Week 12 ]

Locations (74)

Find similar trials in Mesa, AZ

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