Clinical trial NCT01251120: A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis
Official title: A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, over the age of 18 years
* Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
* DAS28 \>3.2
* Swollen joint count (SJC) \>/=6 (66 joint count), and tender joint count (TJC) \>/=6 (68 joint count)
* Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
* Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA

Primary outcomes:
measure: Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Month 12
Secondary outcomes:
measure: Number of Hours Absent From Work
timeFrame: Baseline and 6 and 12 months
measure: Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28
timeFrame: Month 6
measure: Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria
timeFrame: Months 6 and 12
measure: Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)
timeFrame: Months 6 and 12
measure: Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores
timeFrame: Baseline and Months 6 and 12
measure: Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score
timeFrame: Baseline and Months 6 and 12
measure: Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Baseline and Months 6 and 12
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Hämeenlinna
country: Finland
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: Riihimäki
country: Finland
city: Rovaniemi
country: Finland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: