A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tocilizumab [RoActemra/Actemra] — DRUG
  Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks.
• adalimumab — DRUG
  Adalimumab 40 mg SC every 2 weeks.
• placebo to tocilizumab — DRUG
  Placebo to tocilizumab IV every 4 weeks for 24 weeks.
• placebo to adalimumab — DRUG
  Placebo to adalimumab SC every 2 weeks for 24 weeks.
• methotrexate — DRUG
  Methotrexate 10-25 mg weekly.
• folate — DRUG
  Folate at least 5 mg weekly.

Study Details

This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

Key Dates

Start date

May 31, 2011

Status verified

Jan 2014

Primary completion

Aug 31, 2012

Completion

Aug 31, 2012

Study Design

Enrollment

96 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab + Methotrexate
  Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
• Active Comparator: Adalimumab + Methotrexate
  Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.

Primary Outcome Measure

Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 [ Time Frame: Week 24 ]

Locations (107)

Find similar trials in Huntsville, AL

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