Clinical trial NCT01217814: Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
Official title: A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-α Antagonists
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2010-10-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.

Secondary Objectives:

* To assess the safety of sarilumab;
* To document the pharmacokinetic profile of sarilumab.

Detailed description: 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).

Eligibility 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;
* Participant 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 with MTX 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12
timeFrame: Week 12
measure: Disease Activity Score for 28 Joints (DAS28) at Week 12
timeFrame: Week 12
measure: European League Against Rheumatism (EULAR) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12
timeFrame: Week 12
measure: Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab
timeFrame: Week 12
Other outcomes:
Locations:
city: Freehold
country: United States
facility: Investigational Site Number 840026
state: New Jersey
city: New York
country: United States
facility: Investigational Site Number 840043
state: New York
city: Jackson
country: United States
facility: Investigational Site Number 840025
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170004
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170005
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170007
city: Uherske Hradiste
country: Czechia
facility: Investigational Site Number 203002
city: Firenze
country: Italy
facility: Investigational Site Number 380002
city: Genova
country: Italy
facility: Investigational Site Number 380005
city: Durango
country: Mexico
facility: Investigational Site Number 484008
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Oviedo
country: Spain
facility: Investigational Site Number 724004
city: Valencia
country: Spain
facility: Investigational Site Number 724002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: