This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment tocilizumab [roactemra/actemra]
Phase phase 3
Sponsor Hoffmann-La Roche
Start date February 2014
End date September 2015
Trial size 139 participants
Trial identifier NCT02001987, ML28693


This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of RoActemra/Actemra as a monotherapy or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic DMARDs or biologic therapy. 162 mg RoActemra/Actemra will be administered once a week by subcutaneous injection for up to 76 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
tocilizumab [roactemra/actemra]
162 mg administered once weekly by subcutaneous injection.

Primary Outcomes

Change in disease activity score 28-erythrocyte sedimentation rate (DAS28-ESR)
time frame: 24 weeks

Secondary Outcomes

Change in ACR/EULAR response
time frame: 24 weeks and up to 76 weeks
Change in disease activity (CDAI/SDAI)
time frame: 24 weeks and up to 76 weeks
Change in joint swelling/tenderness (SJC/TJC)
time frame: 24 weeks and up to 76 weeks
Incidence of adverse events
time frame: 24 weeks and up to 76 weeks
Changes in ultrasound assessment of joint inflammation (synovitis ultrasound scoring system)
time frame: 24 weeks
Incidence of anti-therapeutic antibodies
time frame: 24 weeks and up to 76 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients > / = 18 years of age - Patients with a diagnosis of active RA according to the revised ACR criteria or EULAR/ACR criteria and receiving outpatient treatment - Oral corticosteroids (< / = 10 mg/day prednisone or equivalent) nonsteroidal anti-inflammatory drugs (NSAIDs), and permitted non-biologic DMARDs are allowed if on a stable dose regimen for > / = 20 mm/h and swollen joint count (SJC) > / = 3 (based on 44 joints) - Inadequate response (IR) to tumor necrosis factor, Abatacept and/or non-biological disease-modifying antirheumatic drugs (DMARDs) 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; Secondary Sjögren's syndrome with RA is permitted. - Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16 - Prior history of current inflammatory joint disease other than RA - Exposure to RoActemra/Actemra at any time prior to Baseline - Treatment with any investigational agent within 4 weeks of Screening - Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies or any alkylating agents such as chlorambucil, or with total lymphoid irradiation - Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline - Intraarticular or parenteral corticosteroids within 4 weeks prior to Baseline - Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline - History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies - Serious uncontrolled concomitant disease or other significant condition - History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease - Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections - Any infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening - Active TB requiring treatment within the previous 3 years - Positive for hepatitis B or C - Primary or secondary immunodeficiency disorder - Active cancer, or cancer diagnosed within the previous 10 years (except for non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated of excised and is considered resolved), or breast cancer diagnosed within the previous 20 years - History of alcohol, drug, or chemical abuse within 1 year prior to Screening - Neuropathies or other conditions that might interfere with pain evaluation

Additional Information

Official title A Multicenter Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.