Status:
COMPLETED
A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid art...
Eligibility Criteria
Inclusion
- Body weight \</=150 kg
- Active moderate to severe rheumatoid arthritis (DAS28 \>/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1)
- Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for participants with a body weight \<50 kg or calculated glomerular filtration rate (or creatinine clearance) \<60 milliliters per minute (mL/min)
- History of parenteral (SC or intramuscular \[IM\]) MTX is allowed, but not within 6 weeks prior to treatment (Day 1). Participants must not have a documented, clinically significant intolerance to oral MTX and must be receiving oral MTX at a dose of 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- Participants who have received one prior anti-tumor necrosis factor (TNF) must have discontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for at least 6 months prior to screening
- Oral corticosteroids must have been \</=10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (Day 1)
- Participants receiving treatment on an outpatient basis
Exclusion
- Documented medical history of significant intolerance to oral MTX \>/=15 mg/week
- Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs) within 8 weeks of screening
- Previous treatment with abatacept, rituximab, tofacitinib, or anakinra
- Treatment with parenteral corticosteroids within 4 weeks prior to treatment
- Previous treatment with cell-depleting therapies or alkylating agents
- Previous treatment with TCZ
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases, psoriasis, multiple sclerosis)
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Functional Class IV according to the revised (1987) ACR criteria for rheumatoid arthritis
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of significant uncontrolled concomitant diseases; uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
- Active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
- Active tuberculosis requiring treatment within the previous 3 years
- History of or currently active primary or secondary immunodeficiency
- Pregnant or breast-feeding women
- Positive for hepatitis B or hepatitis C infection
- For potential MRI substudy participants: the presence of any metal-containing device or object in the body
Key Trial Info
Start Date :
November 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2016
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT01855789
Start Date
November 7 2013
End Date
October 14 2016
Last Update
December 26 2017
Active Locations (155)
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1
Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States, 36207
2
Uni Of Alabama,Birmingham; Medicine - Rheumatology
Birmingham, Alabama, United States, 35294
3
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
4
Clnical & Translational Reseach Center for Alabama, PC
Tuscaloosa, Alabama, United States, 35406