Clinical trial NCT01235507: A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
Official title: Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-05
Enrollment: 71
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 RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis (RA)
* On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
* Oral corticosteroids must have been at stable dose of \</= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
* 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 study entry
* Rheumatic autoimmune disease other than RA
* Functional class IV according to American College of Rheumatology (ACR) classification
* Prior history of or current inflammatory joint disease other then RA
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Treatment with any biologic drug that is used in the treatment or RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Positive for HIV

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
timeFrame: Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcomes:
measure: Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28
timeFrame: Weeks 8, 16 and 24
measure: Swollen and Tender Joint Counts
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Physician's Global Assessment of Disease Activity
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Participant's Global Assessment of Disease Activity
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Participant's Global Assessment of Pain
timeFrame: Baseline, Weeks 8, 16 and 24
measure: CRP Levels
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Weeks 8, 16 and 24
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Tuzla
country: Bosnia and Herzegovina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: