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 - Full Text View

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: adalimumab Drug: leflunomide Drug: methotrexate Drug: MLTA3698A Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium Leflunomide Adalimumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Tender joint count [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Swollen joint count [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Investigator Global Assessment of Disease Activity [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Patient Global Assessment of Pain and Disease Activity [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Health Assessment Questionnaire Disability Index [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Patient's Global Health or Short Form Health Survey (SF-36) [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
European League Against Rheumatism response rate [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Serum C-reactive protein levels [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Erythrocyte sedimentation rate [ Time Frame: Day 85 ] [ Designated as safety issue: No ]

Enrollment:	210210
Study Start Date:	November 2010
Estimated Study Completion Date:	January 2013
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: leflunomide Stable dose if not on methotrexate Drug: methotrexate Stable dose if not on leflunomide Drug: MLTA3698A Subcutaneous repeating dose
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225393

Show 67 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

John C. Davis, Jr., M.D., M.P.H.

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01225393 History of Changes
Other Study ID Numbers:	ALT4864g, GA00932
Study First Received:	October 18, 2010
Last Updated:	August 23, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
Adalimumab
Antirheumatic Agents
Methotrexate
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 21, 2013