This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments dmard, tocilizumab [roactemra/actemra]
Phase phase 3
Sponsor Hoffmann-La Roche
Start date November 2013
End date August 2016
Trial size 100 participants
Trial identifier NCT01941095, 2013-000359-42, ML28695


This multicenter, open-label, single arm study will evaluate the safety and efficacy of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with active rheumatoid arthritis who are either naïve to or have an inadequate response to prior non-biologic or/and biologic DMARDs. The anticipated time on study treatment is 52 weeks. Those patients who will complete the 60-week study period and have achieved DAS28 remission or a good EULAR response at 52 weeks will be eligible to enter the extension phase until RoActemra/Actemra is commercially available and reimbursed in Greece.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Permitted non-biologic disease-modifying antirheumatic drugs, at a stable dose that was initiated at least 4 weeks prior to baseline, are: azathioprine, chloroquine, hydroxychloroquine, leflunomide, methotrexate, and sulfasalazine. Treatment is according to standard of care.
tocilizumab [roactemra/actemra]
162 mg SC weekly

Primary Outcomes

Proportion of patients achieving clinical remission as measured by Disease Activity Score 28 (DAS28) < 2.6 at Week 24
time frame: 24 weeks

Secondary Outcomes

Proportion of patients who maintain DAS28 remission/low disease activity from Week 24 to Week 52 on RoActemra/Actemra monotherapy
time frame: From Week 24 to Week 52
Proportion of patients who achieve DAS28 remission/low disease activity up to Week 52 for patients with intensification of methotrexate/non-biologic DMARDs in combination with RoActemra/Actemra since Week 24 to Week
time frame: From Week 24 to Week 52
Change in American College of Rheumatology (ACR) scores
time frame: from baseline to Week 52
Change in European League Against Rheumatism (EULAR) criteria
time frame: from baseline to Week 52
Change in Simplified/Clinical Disease Activity Index (SDAI/CDAI)
time frame: from baseline to Week 52
Change in Tender/Swollen Joint Count (TJC/SJC)
time frame: from baseline to Week 52
Proportion of patients with corticosteroid reduction/discontinuation
time frame: 52 weeks
Safety: Incidence of adverse events
time frame: 60 weeks
Incidence of anti-tocilizumab antibodies
time frame: 52 weeks
Soluble interleukin-6 receptor (sIL-6R) levels
time frame: 52 weeks
Pharmacokinetics: Plasma concentrations
time frame: 52 weeks
Patient reported outcomes: Global Assessment/Pain visual analogue scales (PGA/Pain-VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI)
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Diagnosis of active rheumatoid arthritis according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria - Either naive to MTX and/or other non-biologic DMARD treatment or having inadequate response (inefficacy/intolerance) to previous non-biologics, and/or having inadequate response (inefficacy/intolerance) to previous biologic DMRADs (including Tumor necrosis factor inhibitors or Abatacept when this was assigned as first-line biologic) - Oral corticosteroids (/= 4 weeks prior to baseline - Permitted non biologic DMARDs are allowed if a stable dose for at least 4 weeks prior ro baseline - Receiving treatment on an output basis, not including RoActemra/Actemra (tocilizumab) - Females of childbearing potential must agree to use a reliable means of contraception during the study; females of childbearing potential must use a reliable means of contraception for at least 3 month following the last dose of RoActemra/Actemra 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 or current inflammatory joint disease other than RA - Exposure to tocilizumab (either IV or SC) at any time prior to baseline - Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of screening - Previous treatment with any cell-depending therapies - Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline - History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies - Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease - Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections - Any major episode of infection requiring hospitalization of 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 surface or hepatitis C infection - Primary or secondary immunodeficiency (history of or currently active) - Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured) , or breast cancer diagnosed within the previous 20 years - Pregnancy or breast feeding women - Neuropathies or other conditions that interfere with pain evaluation

Additional Information

Official title Multicenter, Open-label, Phase IIIb Study to Evaluate the Safety, Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-biologic Disease-modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.