Clinical trial NCT01063062: A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
Official title: A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 107
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 single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[RoActemra/Actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab \[RoActemra/Actemra\] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age
* Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) \> 3.2 at screening)
* Patients with active RA after more than 12 weeks of treatment with DMARDs
* Patients with inadequate response to a stable dose of non-biologic DMARD

Exclusion Criteria:

* Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Prior history of or current inflammatory joint disease other than RA

Primary outcomes:
measure: Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity
timeFrame: Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)
measure: Time to DAS28 Low Disease Activity
timeFrame: 24 Weeks
Secondary outcomes:
measure: Percentage of Participants Achieving DAS28 Clinically Significant Improvement
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24
measure: Time to DAS28 Clinically Significant Improvement
timeFrame: 24 Weeks
measure: Percentage of Participants Achieving DAS28 Remission
timeFrame: Weeks 4, 8, 12, 16, 20, 24
measure: Time to DAS28 Remission
timeFrame: 24 Weeks
measure: Disease Activity Score 28 (DAS28)
timeFrame: Weeks 4, 8, 12, 16, 20, 24
measure: C-Reactive Protein (CRP)
timeFrame: Weeks 4, 8, 12, 16, 20, 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Weeks 4, 8, 12, 16, 20, 24
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 24 Weeks
measure: Number of Participants With AE and SAE Related Discontinuation
timeFrame: 24 Weeks
measure: Number of Participants With Serious Infections
timeFrame: 24 Weeks
measure: Number of Participants With Elevated AST (SGOT) and ALT (SGPT)
timeFrame: Week 24
measure: Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines
timeFrame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
measure: Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines
timeFrame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
measure: Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines
timeFrame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
measure: Number of Participants With Elevated Triglyceride According to ATPIII Guidelines
timeFrame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospital; Rheumatology
city: Alexandria
country: Egypt
facility: Alexandria University
city: Banha
country: Egypt
facility: Banha Educational Hospital; Rheumatology
city: Cairo
country: Egypt
facility: Kasr El Ainy Hospital; Rheumatology
city: Cairo
country: Egypt
facility: Ain Shams University Hospital; Rheumatology
city: Cairo
country: Egypt
facility: Bab El Sheereya Hospital; Rheumatology
city: Cairo
country: Egypt
facility: El Hussein University Hospital; Rheumatology
city: Cairo
country: Egypt
facility: Kasr El Ainy Hospital
city: Cairo
country: Egypt
facility: Manial Specialized Hospital; Rheumatology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: