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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: SAR153191 (REGN88)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328522

PKM12058

U1111-1119-2883 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

SAR153191 drug product 1

Experimental group

Description:

SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Treatment:

Drug: SAR153191 (REGN88)

SAR153191 drug product 2

Experimental group

Description:

SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Treatment:

Drug: SAR153191 (REGN88)