Clinical trial NCT01353859: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving Low Disease Activity Score
timeFrame: Week 24
Secondary outcomes:
measure: Time to Achieve Low Disease Activity (DAS28 ≤3.2)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Time to Clinically Significant Improvement in DAS28
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Time to Achieve DAS28 Remission (DAS28 <2.6)
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With DAS28 <3.2 by Visit
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response
timeFrame: Week 24
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: C-Reactive Protein Levels
timeFrame: Baseline, Weeks 4, 8, 12,16, 20, and 24
Other outcomes:
Locations:
city: Bandung
country: Indonesia
city: Central Jakarta
country: Indonesia
city: East Java
country: Indonesia
city: Malang
country: Indonesia
city: Yogyakarta
country: Indonesia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: