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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225393
• Other study ID #: ALT4864g
• Secondary ID: GA00932
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2010
• Last updated: November 1, 2016
• Start date: November 2010

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Chile,  Germany,  Hungary,  Mexico,  Peru,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR		Day 85	No
Primary	Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A		Length of study (through Day 85)	No
Secondary	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 )		Day 85	No
Secondary	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 )		Day 85	No
Secondary	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)		Day 85	No
Secondary	Tender joint count		Day 85	No
Secondary	Swollen joint count		Day 85	No
Secondary	Investigator Global Assessment of Disease Activity		Day 85	No
Secondary	Patient Global Assessment of Pain and Disease Activity		Day 85	No
Secondary	Health Assessment Questionnaire Disability Index		Day 85	No
Secondary	Patient's Global Health or Short Form Health Survey (SF-36)		Day 85	No
Secondary	European League Against Rheumatism response rate		Day 85	No
Secondary	Serum C-reactive protein levels		Day 85	No
Secondary	Erythrocyte sedimentation rate		Day 85	No