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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01225393
• Date of registration: 18/10/2010
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: 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
• Scientific 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
• Date of first enrolment: November 2010
• Target sample size: 211
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01225393
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: John C. Davis, Jr., M.D., M.P.H.
• Affiliation: Genentech, Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: placebo

Drug: methotrexate

Drug: adalimumab

Drug: leflunomide

Drug: MLTA3698A

Primary Outcome(s)

Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR [Time Frame: Day 85]

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(s)

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]

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]

Serum C-reactive protein levels [Time Frame: Day 85]

Health Assessment Questionnaire Disability Index [Time Frame: Day 85]

Tender joint count [Time Frame: Day 85]

Investigator Global Assessment of Disease Activity [Time Frame: Day 85]

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]

European League Against Rheumatism response rate [Time Frame: Day 85]

Patient Global Assessment of Pain and Disease Activity [Time Frame: Day 85]

Patient's Global Health or Short Form Health Survey (SF-36) [Time Frame: Day 85]

Swollen joint count [Time Frame: Day 85]

Erythrocyte sedimentation rate [Time Frame: Day 85]

Secondary ID(s)

ALT4864g

GA00932

Source(s) of Monetary Support

Please refer to primary and secondary sponsors