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Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

REGN88

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA

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 kg 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
For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1
For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study.

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
Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Dose 1

Dose 2

Dose 3

Arm Description

First dose of SC REGN88

Second dose of SC REGN88

Third dose of SC REGN88

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate

Secondary Outcome Measures

To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88

Full Information

NCT ID

NCT01055899

First Posted

January 25, 2010

Last Updated

September 27, 2013

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01055899

Brief Title

Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered 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

July 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.

Detailed Description

This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.

6. Conditions and Keywords

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

Rheumatoid Arthritis

Keywords

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1

Arm Type

Experimental

Arm Description

First dose of SC REGN88

Arm Title

Dose 2

Arm Type

Experimental

Arm Description

Second dose of SC REGN88

Arm Title

Dose 3

Arm Type

Experimental

Arm Description

Third dose of SC REGN88

Intervention Type

Biological

Intervention Name(s)

REGN88

Intervention Description

Single SC Dose

Intervention Type

Biological

Intervention Name(s)

REGN88

Intervention Description

Single SC Dose

Intervention Type

Biological

Intervention Name(s)

REGN88

Intervention Description

Single SC Dose

Primary Outcome Measure Information:

Title

To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate

Time Frame

113 Days

Secondary Outcome Measure Information:

Title

To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88

Time Frame

113 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 kg 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 For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1 For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. 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 Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen Radin, M.D.

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Duncansville

State/Province

Pennsylvania

Country

United States

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

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