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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

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ClinicalTrials.gov Identifier: NCT01225393
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MLTA3698A Drug: adalimumab Drug: leflunomide Drug: methotrexate Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Parallel-Group 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 Patient With Active Rheumatoid Arthritis
Study Start Date : November 2010
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: A Drug: MLTA3698A
Subcutaneous repeating dose

Drug: leflunomide
Stable dose if not on methotrexate

Drug: methotrexate
Stable dose if not on leflunomide

Active Comparator: B Drug: adalimumab
Subcutaneous repeating dose

Drug: leflunomide
Stable dose if not on methotrexate

Drug: methotrexate
Stable dose if not on leflunomide

Drug: placebo
Subcutaneous repeating dose

Placebo Comparator: C Drug: leflunomide
Stable dose if not on methotrexate

Drug: methotrexate
Stable dose if not on leflunomide

Drug: placebo
Subcutaneous repeating dose




Primary Outcome Measures :
  1. Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR [ Time Frame: Day 85 ]
  2. Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A [ Time Frame: Length of study (through Day 85) ]

Secondary Outcome Measures :
  1. ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response ) [ Time Frame: Day 85 ]
  2. ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response ) [ Time Frame: Day 85 ]
  3. ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response) [ Time Frame: Day 85 ]
  4. Tender joint count [ Time Frame: Day 85 ]
  5. Swollen joint count [ Time Frame: Day 85 ]
  6. Investigator Global Assessment of Disease Activity [ Time Frame: Day 85 ]
  7. Patient Global Assessment of Pain and Disease Activity [ Time Frame: Day 85 ]
  8. Health Assessment Questionnaire Disability Index [ Time Frame: Day 85 ]
  9. Patient's Global Health or Short Form Health Survey (SF-36) [ Time Frame: Day 85 ]
  10. European League Against Rheumatism response rate [ Time Frame: Day 85 ]
  11. Serum C-reactive protein levels [ Time Frame: Day 85 ]
  12. Erythrocyte sedimentation rate [ Time Frame: Day 85 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening
  • 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:

  • Pregnant, planning to become pregnant during the study, or breastfeeding
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225393


  Show 67 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: John C. Davis, Jr., M.D., M.P.H. Genentech, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01225393     History of Changes
Other Study ID Numbers: ALT4864g
GA00932 ( Other Identifier: Hoffmann-La Roche )
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Leflunomide
Adalimumab
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents