A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/27/2017
Start Date:November 7, 2013
End Date:October 14, 2016

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A Randomized, Double-Blind Trial Assessing the Impact of Methotrexate Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate Therapy

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 arthritis who have an inadequate response to current MTX therapy. Participants
will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose
orally in an open-label manner for 24 weeks. Participants with a disease activity score based
on 28 joints (DAS28) less than or equal to ( continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52.
Participants without a DAS28 score non-randomized open-label manner up to Week 52.


Inclusion Criteria:

- Body weight
- 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 for at least 25 out of 28 days prior to treatment (Day 1)

- Participants receiving treatment on an outpatient basis

Exclusion Criteria:

- 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
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321 East 10th Street
Anniston, Alabama 36207
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2401 North Commerce Street
Ardmore, Oklahoma 73401
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Asheville, North Carolina 28803
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12605 East 16th Avenue
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Austin, Texas 78731
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21097 Northeast 27th Court
Aventura, Florida 33180
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3406 College Street
Beaumont, Texas 77701
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2000 6th Avenue South
Birmingham, Alabama 35294
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Bismarck, North Dakota 58501
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Bridgeport, Connecticut 06606
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186 Joralemon Street
Brooklyn, New York 11201
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Charleston, South Carolina 29406
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