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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011959
• Other study ID #: 6R88-RA-0802
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2009
• Last updated: September 27, 2013
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.

Description:

This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.

This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo		10 weeks	Yes
Secondary	To evaluate exploratory efficacy endpoints		over 10 weeks	No