A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026519
• Other study ID #: 6R88-RA-0803
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2009
• Last updated: September 27, 2013
• Start date: September 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female =18 years of age

2. Subjects must weigh >50 and <100 kg

3. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III

Exclusion Criteria:

1. A history of Listeriosis or active tuberculosis (TB)

2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit

3. History of prior articular or prosthetic joint infection

4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule

5. Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• REGN88
Single dose of REGN88 and 43 day follow up.

Other:
• Placebo
Placebo to match REGN88 administration

Locations

Country	Name	City	State
Russian Federation	Institute of Rheumatology under the Russian Academy of Medical Sciences	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hs-C reactive protein (hs-CRP)		43 Days	No
Secondary	Subject's Assessment of Pain and Subject's Global Assessment of Disease activity		43 Days	No