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Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients

NCT ID: NCT01328522

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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Primary Objective:

Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

Secondary Objective:

Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

Detailed Description

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The duration of the study period per subject is 5-7 weeks broken down as follows:

* Screening: 1 to 14 days,
* Treatment: 1 day (2 overnight stays at the study site),
* Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SAR153191 drug product 1

SAR153191 drug product 1 in a single injection.

Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Group Type EXPERIMENTAL

SAR153191 (REGN88)

Intervention Type DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous

SAR153191 drug product 2

SAR153191 drug product 2 in a single injection.

Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Group Type EXPERIMENTAL

SAR153191 (REGN88)

Intervention Type DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous

Interventions

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SAR153191 (REGN88)

Pharmaceutical form:solution

Route of administration: subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of rheumatoid arthritis (RA) \> or = 3 months duration.
* Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.

Exclusion Criteria

* Autoimmune disease other than RA.
* History of acute inflammatory joint disease other than RA.
* Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
* Latent or active tuberculosis.
* Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
* Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).
* Received tuberculosis vaccination within 12 months prior to screening
* Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.
* Known latex sensitivity.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840003

Beverly Hills, California, United States

Site Status

Investigational Site Number 840001

Ocala, Florida, United States

Site Status

Investigational Site Number 840004

Duncansville, Pennsylvania, United States

Site Status

Investigational Site Number 840002

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1119-2883

Identifier Type: OTHER

Identifier Source: secondary_id

PKM12058

Identifier Type: -

Identifier Source: org_study_id