A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

Roche

Status and phase

Terminated

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Drug: DMARD

Study type

Interventional

Funder types

Industry

Identifiers

NCT01251120

ML25346

Details and patient eligibility

About

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, over the age of 18 years
Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
DAS28 >3.2
Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6 (68 joint count)
Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion criteria

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
Prior history of or current inflammatory joint disease other than RA