This trial has been completed.

Condition rheumatoid arthritis
Treatment tocilizumab [roactemra/actemra]
Phase phase 3
Sponsor Hoffmann-La Roche
Start date February 2014
End date December 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

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 November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.