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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

REGN88

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female ≥18 years of age
Subjects must weigh >50 and <100 kg
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:

A history of Listeriosis or active tuberculosis (TB)
Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
History of prior articular or prosthetic joint infection
History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
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

Sites / Locations

Institute of Rheumatology under the Russian Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Dose 1

Dose 2

Dose 3

Dose 4

Arm Description

Active dose

Active 3

Placebo dose

Outcomes

Primary Outcome Measures

hs-C reactive protein (hs-CRP)

Secondary Outcome Measures

Subject's Assessment of Pain and Subject's Global Assessment of Disease activity

Full Information

NCT ID

NCT01026519

First Posted

December 2, 2009

Last Updated

September 27, 2013

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01026519

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1

Arm Type

Experimental

Arm Description

Active dose

Arm Title

Dose 2

Arm Type

Experimental

Arm Description

Active dose

Arm Title

Dose 3

Arm Type

Experimental

Arm Description

Active 3

Arm Title

Dose 4

Arm Type

Placebo Comparator

Arm Description

Placebo dose

Intervention Type

Drug

Intervention Name(s)

REGN88

Intervention Description

Single dose of REGN88 and 43 day follow up.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo to match REGN88 administration

Primary Outcome Measure Information:

Title

hs-C reactive protein (hs-CRP)

Time Frame

43 Days

Secondary Outcome Measure Information:

Title

Subject's Assessment of Pain and Subject's Global Assessment of Disease activity

Time Frame

43 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥18 years of age Subjects must weigh >50 and <100 kg 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: A history of Listeriosis or active tuberculosis (TB) Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit History of prior articular or prosthetic joint infection History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen Radin, MD

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Institute of Rheumatology under the Russian Academy of Medical Sciences

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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