Clinical trial NCT01011959: A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
timeFrame: 10 weeks
Secondary outcomes:
measure: To evaluate exploratory efficacy endpoints
timeFrame: over 10 weeks
Other outcomes:
Locations:
city: Santa Maria
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Idaho Falls
country: United States
state: Idaho
city: Worcester
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Flowood
country: United States
state: Mississippi
city: Kalamzaoo
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Hixson
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Allen Radin, MD
role: STUDY_DIRECTOR
References: