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A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis (RA) Who Have Failed Previous TNF-α Antagonists


Phase 2
18 Years
75 Years
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis (RA) Who Have Failed Previous TNF-α Antagonists


The duration of the study period for each participant was approximately 22 weeks; including
up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety
follow-up period.

Participants who completed the 12-week treatment period were offered enrollment in a
separate long-term extension study (LTS11210/NCT01146652).

Inclusion Criteria


Inclusion criteria:

- Diagnosis of rheumatoid arthritis ≥6 months duration and American College of
Rheumatology [ACR] Class I-III functional status at screening and baseline visits;

- Active disease defined as:

- At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and
baseline visits, and

- hs-C-Reactive Protein [hs-CRP] >10 g/L or Erythrocyte Sedimentation Rate [ESR]
>28 mm/hr at screening visit;

- Continuous treatment with Methotrexate for at least 12 weeks and on stable dose
(minimum 10 mg/week) for at least 6 weeks prior to the screening visit;

- Patient considered as Primary TNF-α blocker nonresponder. i.e.:

- Appropriate for previous TNF-α blocker therapy

- Lack of adequate clinical response after at least 3 months TNF-α blocker therapy
(up to 2 agents) with Methotrexate or other synthetic disease modifying
anti-rheumatic drug [DMARD] co-therapy.

Exclusion criteria:

- Age <18 years or >75 years;

- Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to
utilize adequate contraception or not to become pregnant during the entire study;

- Fever (>38°C), or chronic, persistent, or recurring infection(s);

- History of demyelinating disease;

- Current underlying hepatobiliary disease.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Percentage of participants who achieve 20% improvement from baseline according to the American College of Rheumatology core set disease activity index [ACR20]

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

ACT11575

NCT ID:

NCT01217814

Start Date:

November 2010

Completion Date:

September 2011

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Investigational Site Number 840026 Freehold, New Jersey  07728
Investigational Site Number 840043 New York, New York  11201
Investigational Site Number 840025 Jackson, Tennessee  38305
Investigational Site Number 840038 Austin, Texas  78705