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