Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a Blockers

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01217814
• Date of registration: 07/10/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a Blockers
• Scientific 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-a Antagonists
• Date of first enrolment: November 2010
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01217814
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Brazil, Canada, Colombia, Czech Republic, Czechia, Germany, Hungary, Italy, Mexico, Norway, Spain, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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-a blocker nonresponder. i.e.:

- Appropriate for previous TNF-a blocker therapy

- Lack of adequate clinical response after at least 3 months TNF-a 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: methotrexate (MTX)

Drug: Sarilumab

Drug: Folic/folinic acid

Drug: Placebo

Drug: Golimumab

Primary Outcome(s)

Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12 [Time Frame: Week 12]

Disease Activity Score for 28 Joints (DAS28) at Week 12 [Time Frame: Week 12]

Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab [Time Frame: Week 12]

European League Against Rheumatism (EULAR) Response at Week 12 [Time Frame: Week 12]

Secondary ID(s)

2010-021020-94

ACT11575

U1111-1115-3763

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 01/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01217814