A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01353859
• Date of registration: 13/05/2011
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
• Scientific title: An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
• Date of first enrolment: March 2011
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01353859
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Greece, Indonesia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration

- Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)

- Inadequate clinical response to stable dose of non-biologic DMARD (either single or in
combination)

Exclusion Criteria:

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following enrollment

- Autoimmune disease other than RA

- History of or current inflammatory joint disease other than RA

- Previous treatment with any biologic drug that is used in the treatment of RA

- Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline

- Impaired liver, renal or hematologic function

- Active current or history of recurrent infection

- History of or currently active primary or secondary immunodeficiency



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: tocilizumab [RoActemra/Actemra]

Drug: methotrexate

Primary Outcome(s)

Percentage of Participants Achieving Low Disease Activity Score [Time Frame: Week 24]

Secondary Outcome(s)

C-Reactive Protein Levels [Time Frame: Baseline, Weeks 4, 8, 12,16, 20, and 24]

Time to Clinically Significant Improvement in DAS28 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Time to Achieve DAS28 Remission (DAS28 <2.6) [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Time to Achieve Low Disease Activity (DAS28 =3.2) [Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24]

Erythrocyte Sedimentation Rate [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]

Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6) [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24]

Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response [Time Frame: Week 24]

Percentage of Participants With DAS28 <3.2 by Visit [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24]

Percentage of Participants With a Clinically Significant Improvement in DAS28 Score [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Secondary ID(s)

ML25536

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01353859