Clinical trial NCT01587989: A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
Official title: A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 77
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 multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Rheumatoid arthritis of \>/= 1 year duration
* Mild to moderate disease activity at screening (DAS 28 \</= 4.5 and \>2.6)
* On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
* Body weight \</= 150 kg
* Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline

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
* Functional class IV American College of Rheumatology (ACR) Classification
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* Treatment with a biologic agent at any time prior to baseline
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with tocilizumab
* Pregnant or lactating women
* Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* History of or currently active primary or secondary immunodeficiency
* Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV infection

Primary outcomes:
measure: Change From Week 12 (Randomization) to Week 24 in DAS28
timeFrame: Weeks 12 and 24
Secondary outcomes:
measure: Percentage of Participants With DAS28 Remission at Week 24
timeFrame: Week 24
measure: vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24
timeFrame: Week 24
measure: Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Weeks 12 and 24
measure: Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score
timeFrame: Weeks 12 and 24
measure: Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores
timeFrame: Weeks 12 and 24
measure: Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score
timeFrame: Week 24
Other outcomes:
Locations:
city: Graz-Eggenberg
country: Austria
city: Graz
country: Austria
city: Hollabrunn
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Salzburg
country: Austria
city: Stockerau
country: Austria
city: Wels
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: