A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]; Drug: methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235507

ML25303

Details and patient eligibility

About

This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Active moderate to severe rheumatoid arthritis (RA)
• On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
• Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
• Body weight </= 150 kg

Exclusion criteria

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
• Rheumatic autoimmune disease other than RA
• Functional class IV according to American College of Rheumatology (ACR) classification
• Prior history of or current inflammatory joint disease other then RA
• Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
• Treatment with any biologic drug that is used in the treatment or RA
• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• Known active current or history of recurrent infection
• History of or currently active primary or secondary immunodeficiency
• Positive for HIV

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: methotrexate

Drug: tocilizumab [RoActemra/Actemra]