A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01011959
• Date of registration: 10/11/2009
• Prospective Registration: No
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
• Scientific title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
• Date of first enrolment: December 2008
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01011959
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Allen Radin, MD
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with an established diagnosis of Rheumatoid Arthritis

- Patients currently treated with concomitant methotrexate for at least 12 weeks, with
a stable dose for at least 6 weeks

Exclusion Criteria:

- Persistent chronic or current active infections

- Patients who have taken anakinra within 2 weeks

- Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold,
penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks

- Patients who have taken adalimumab within 6 weeks

- Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab
within 12 weeks

- Patients who have taken leflunomide or rituximab within 6 months

- Patients who have had prior treatment with tocilizumab or any other anti-IL-6
medication

- Significant arthritis or other medical condition that could interfere with study
evaluations

- Participation in any clinical research study evaluating another investigational drug
within 30 days



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: REGN88

Primary Outcome(s)

Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo [Time Frame: 10 weeks]

Secondary Outcome(s)

To evaluate exploratory efficacy endpoints [Time Frame: over 10 weeks]

Secondary ID(s)

6R88-RA-0802

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi