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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01026519
• Collaborator: Sanofi (Industry)
• Enrollment: 32
• Location: 1
• Arms: 4
• Duration (Months): 8
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: REGN88; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 Active dose	Drug: REGN88; Single dose of REGN88 and 43 day follow up.
Experimental: Dose 2 Active dose	Drug: REGN88; Single dose of REGN88 and 43 day follow up.
Experimental: Dose 3 Active 3	Drug: REGN88; Single dose of REGN88 and 43 day follow up.
Placebo Comparator: Dose 4 Placebo dose	Other: Placebo; Placebo to match REGN88 administration

Outcome Measures

Primary Outcome Measures

1. hs-C reactive protein (hs-CRP) [43 Days]

Secondary Outcome Measures

1. Subject's Assessment of Pain and Subject's Global Assessment of Disease activity [43 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Rheumatology under the Russian Academy of Medical Sciences	Moscow		Russian Federation

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Allen Radin, MD, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01026519
• Other Study ID Numbers: 6R88-RA-0803
• First Posted: Dec 4, 2009
• Last Update Posted: Sep 30, 2013
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Sep 30, 2013