Clinical trial NCT01149057: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
Official title: An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2010-06-23
Enrollment: 145
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 study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Active moderate to severe rheumatoid arthritis
* Inadequate response to \>/=3 DMARDs (non-biologic and/or biologic)
* Current treatment at stable dose for \>/=8 weeks
* Etanercept discontinued \>/=2 weeks, Anakinra \>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \>/=16 weeks, and must have proven B-cell repletion

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
* Rheumatic autoimmune disease other than RA
* Functional class IV (American College of Rheumatology Classification)
* Prior history or current inflammatory joint disease other than RA
* Oral corticosteroids at a dose of \>10 mg/day prednisone equivalent
* Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
* Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
* History of or currently active primary or secondary immunodeficiency

Primary outcomes:
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population
timeFrame: Baseline, Week 24
measure: Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population
timeFrame: Baseline, Week 48
measure: Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population
timeFrame: Baseline, Week 72
measure: Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population
timeFrame: Baseline, Week 96
measure: Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population
timeFrame: Baseline, Week 24
measure: Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population
timeFrame: Baseline, Week 48
measure: Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population
timeFrame: Baseline, Week 72
measure: Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population
timeFrame: Baseline, Week 96
Secondary outcomes:
measure: Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study
timeFrame: Baseline, End of the study (up to Week 100)
measure: Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96
timeFrame: Weeks 24, 48, 72 and 96
measure: Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96
timeFrame: Weeks 24, 48, 72 and 96
measure: Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96
timeFrame: Weeks 24, 48, 72 and 96
measure: Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96
timeFrame: Weeks 24, 48, 72 and 96
measure: Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96
timeFrame: Weeks 24, 48, 72 and 96
measure: Change From Baseline in TJC At Weeks 24, 48, 72, and 96
timeFrame: Baseline; Weeks 24, 48, 72 and 96
measure: Change From Baseline in SJC At Weeks 24, 48, 72, and 96
timeFrame: Baseline; Weeks 24, 48, 72 and 96
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96
timeFrame: Weeks 24, 48, 72 and 96
measure: Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96
timeFrame: Baseline; Weeks 20, 44, 72 and 96
measure: C-reactive Protein Level
timeFrame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
measure: Participant Assessment of Pain (VAS)
timeFrame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96
timeFrame: Baseline; Weeks 24, 48, 72 and 96
Other outcomes:
Locations:
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Beer Sheva
country: Israel
city: Beer Yaakov
country: Israel
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: