Clinical trial NCT01610791: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
Official title: A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 121
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 open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis (DAS28 \> 3.2 at screening)
* Inadequate response to DMARDs
* 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 enrollment
* Rheumatic autoimmune disease other than RA
* American College of Rheumatology (ACR) functional class IV
* Prior history of or current inflammatory joint disease other than RA
* Previous treatment with any biologic drug that is used in the treatment of RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Pregnant or lactating women
* Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcomes:
measure: Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
timeFrame: Baseline through Week 24
measure: Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
timeFrame: Baseline through Week 24
measure: Percentage of Participants With Lipid Elevations by Study Visit
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants by DAS28 Response Category
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Time to Achieve Clinically Meaningful Reduction in DAS28
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving Remission (DAS28 <2.6)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Swollen and Tender Joint Counts
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Patient Global Assessment of Disease Activity (VAS)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Physician's Global Assessment of Disease Activity (VAS)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Patient Assessment of of Pain (VAS)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Other outcomes:
Locations:
city: Casablanca
country: Morocco
city: Fés
country: Morocco
city: Khouribga
country: Morocco
city: Kénitra
country: Morocco
city: Marrakech
country: Morocco
city: Meknés
country: Morocco
city: Rabat
country: Morocco
city: Salé
country: Morocco
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: