A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis
NCT ID: NCT01225393
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
211 participants
INTERVENTIONAL
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
MLTA3698A
Subcutaneous repeating dose
leflunomide
Stable dose if not on methotrexate
methotrexate
Stable dose if not on leflunomide
B
adalimumab
Subcutaneous repeating dose
leflunomide
Stable dose if not on methotrexate
methotrexate
Stable dose if not on leflunomide
placebo
Subcutaneous repeating dose
C
leflunomide
Stable dose if not on methotrexate
methotrexate
Stable dose if not on leflunomide
placebo
Subcutaneous repeating dose
Interventions
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MLTA3698A
Subcutaneous repeating dose
adalimumab
Subcutaneous repeating dose
leflunomide
Stable dose if not on methotrexate
methotrexate
Stable dose if not on leflunomide
placebo
Subcutaneous repeating dose
Eligibility Criteria
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Inclusion Criteria
* Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both
* Active disease, defined as: CRP \>= 1.0 mg/dL; swollen joint count \>= 6 (66 joint count); tender joint count \>= 6 (68 joint count)
* Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)
* For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening
* For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening
* For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose
* For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines
Exclusion Criteria
* Clinically significant abnormal laboratory values or abnormal ECG or vital signs
* History of anaphylactic reactions
* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study
* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis
* Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study
* Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John C. Davis, Jr., M.D., M.P.H.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Peoria, Arizona, United States
Los Angeles, California, United States
Upland, California, United States
Ormond Beach, Florida, United States
Lexington, Kentucky, United States
Kalamazoo, Michigan, United States
Flowood, Mississippi, United States
Reno, Nevada, United States
Charleston, South Carolina, United States
San Antonio, Texas, United States
Chesapeake, Virginia, United States
Clarksburg, West Virginia, United States
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Bad Nauheim, , Germany
Berlin, , Germany
Cologne, , Germany
Erfurt, , Germany
Freiburg im Breisgau, , Germany
Herne, , Germany
Kiel, , Germany
Zerbst, , Germany
Békéscsaba, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Veszprém, , Hungary
Culiacán, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexicali, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
México, , Mexico
Monterrey, NL, , Mexico
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
San Isidro, , Peru
San Isidro, , Peru
Bialystok, , Poland
Bialystok, , Poland
Elblag, , Poland
Kościan, , Poland
Krakow, , Poland
Lublin, , Poland
Warsaw, , Poland
Baia Mare, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Galati, , Romania
Torrelavega, Cantabria, Spain
A Coruña, La Coruña, Spain
Seville, Sevilla, Spain
S. Cristobal de La Laguna, Tenerife, Spain
Countries
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References
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Kennedy WP, Simon JA, Offutt C, Horn P, Herman A, Townsend MJ, Tang MT, Grogan JL, Hsieh F, Davis JC. Efficacy and safety of pateclizumab (anti-lymphotoxin-alpha) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study). Arthritis Res Ther. 2014 Oct 30;16(5):467. doi: 10.1186/s13075-014-0467-3.
Other Identifiers
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GA00932
Identifier Type: OTHER
Identifier Source: secondary_id
ALT4864g
Identifier Type: -
Identifier Source: org_study_id