A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo to tocilizumab; Drug: Adalimumab; Drug: Placebo to adalimumab; Drug: Tocilizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119859

2009-015845-21

WA19924

Details and patient eligibility

About

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥ 18 years of age.
• Rheumatoid arthritis of > 6 months duration.
• Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
• All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
• Weight ≤ 150 kg.

Exclusion criteria

• Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
• History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
• Treatment with a biologic agent at any time prior to baseline.
• Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
• Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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326 participants in 2 patient groups

Tocilizumab 8 mg/kg

Experimental group

Description:

Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.

Treatment:

Drug: Tocilizumab

Drug: Placebo to adalimumab

Adalimumab 40 mg

Active Comparator group

Description:

Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.

Treatment:

Drug: Placebo to tocilizumab

Drug: Adalimumab