Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - 75
Updated:	6/29/2017
Start Date:	March 2010
End Date:	October 2013

A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Primary Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of
signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

- reduction of signs and symptoms of rheumatoid arthritis at 24 weeks

- inhibition of progression of structural damage at 52 weeks

- improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical
response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with
active rheumatoid arthritis who were inadequate responders to MTX therapy.

The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B)
broken down as follows:

- Screening: Up to 4 weeks

- Treatment: 12 weeks (Part A) and 52 weeks (Part B)*

- Follow-up: 6 weeks (for participants who would not continue in the long-term extension
study).

'*' Participants successfully completing their treatment period would be offered the
opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).

Inclusion criteria :

- Diagnosis of rheumatoid arthritis ≥3 months duration

- Active disease defined as:

- at least 8/68 tender joints and 6/66 swollen joints,

- high sensitivity C-reactive protein (hs-CRP) >6 mg/l,

- continuous treatment with MTX for at least 12 weeks prior to baseline visit and
on stable dose for at least 6 weeks prior to screening visit.

Part B only:

- Bone erosion based on documented X-ray prior to first study drug intake, or

- Cyclic Citrullinated Peptide (CCP) positive, or

- Rheumatoid Factor (RF) positive.

Exclusion criteria:

- Age <18 years or >75 years.

- Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4
weeks or 12 weeks prior to screening (depending on DMARDs).

- Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic
treatment.

- Any past or current biologic agents for the treatment of rheumatoid arthritis within
3 months.

- Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks
prior to screening visit.

- Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in
dosage within 4 weeks prior to baseline visit.

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

We found this trial at

sites

Clinical Trial Facility in Dallas Texas

Dallas, Texas 75390

from

Dallas, TX