Rheumatoid Arthritis Clinical Trial
Official title:
Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF
Verified date | October 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Saudi Arabia: Ministry of Health |
Study type | Interventional |
This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.
Status | Completed |
Enrollment | 28 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Active moderate to severe rheumatoid arthritis of >/= 6 months duration - >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment - Inadequate clinical response to non-biologic DMARD or anti-TNF therapy - Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug Exclusion Criteria: - Pregnant or lactating women - Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment - Rheumatic autoimmune disease other than RA - Functional class IV (ACR classification) - Prior history of or current joint disease other than RA - Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline - Previous treatment with RoActemra/Actemra - Known active current or history of recurrent infection - History of or currently active primary or secondary immunodeficiency - Active tuberculosis requiring treatment within the previous 3 years - Positive for HIV |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in disease activity score (DAS28) | from baseline to week 24 | No | |
Primary | Proportion of patients achieving remission (DAS28 <2.6) | 24 weeks | No | |
Primary | Time to remission (DAS28 <2.6) | 24 weeks | No | |
Secondary | Safety: Incidence of adverse events | 24 weeks | No | |
Secondary | Response according to American College of Rheumatology (ACR) criteria | 24 weeks | No |
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