Evaluation of SAR153191(REGN88)(Sarilumab) on Top of Methotrexate in Rheumatoid Arthritis Patients (RA-MOBILITY)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01061736
First received: February 2, 2010
Last updated: August 26, 2014
Last verified: November 2013
  Purpose

Primary Objectives:

Part A: To demonstrate that SAR153191 (REGN88) on top of methotrexate (MTX) is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B: To demonstrate that SAR153191 (REGN88) added to MTX is 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 SAR153191 (REGN88) added to MTX is effective in:

- induction of a major clinical response at 52 weeks.

To assess the safety of SAR153191 (REGN88) added to MTX.

To document the pharmacokinetic profile of SAR153191 (REGN88) added to MTX, in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: SAR153191 (REGN88)
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Part A: Percentage of patients who achieved the American College of Rheumatology criteria for improvement ACR20 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Part B: ACR20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Part B: Change in modified Van der Heijde Sharp score (composite index on X-ray assessed through central reading) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Part B: Change in physical function as measured by the change from baseline in HAQ-DI [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part B: Percentage of patients who achieved and maintained (for at least 6 months) an ACR70 response [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 1594
Study Start Date: March 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: SAR153191 (REGN88) Dose 1
SAR153191, 100mg every week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part A: SAR153191 (REGN88) Dose 2
SAR153191, 150mg every week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part A: SAR53191 (REGN88) Dose 3
SAR153191, 100mg, every-other-week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part A: SAR153191 (REGN88) Dose 4
SAR153191, 150mg every-other-week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part A: SAR153191 (REGN88) Dose 5
SAR153191, 200mg every-other-week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Placebo Comparator: Part A: Placebo
Placebo on top of methotrexate
Drug: placebo

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part B: SAR153191 (REGN88) Dose 1
SAR153191, 100mg every week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part B: SAR153191 (REGN88) Dose 2
SAR153191, 150mg every week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part B: SAR153191 (REGN88) Dose 3
SAR153191, 100mg every-other-week on top of methotrexate
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part B: SAR153191 (REGN88) Dose 4
SAR153191, 150mg every-other-week on top of methotrexate (currently used dose after dose selection)
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: Part B: SAR153191 (REGN88) Dose 5
SAR153191, 200mg every-other-week on top of methotrexate (currently used dose after dose selection)
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Placebo Comparator: Part B: Placebo
Placebo on top of methotrexate
Drug: placebo

Pharmaceutical form: solution

Route of administration: subcutaneous


Detailed Description:

The total study duration for a patient is 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 patients who will not continue in the long-term extension study).

'*' Patients successfully completing their treatment period will be offered the opportunity to enter the long term extension study LTS11210 (EXTEND).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061736

  Show 262 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Mark C Genovese, MD, Professor of Medicine Division of Immunonoly and Rheumatology - Stanford University - USA
Study Chair: TWJ Huizinga, Prof Dr Dpt of Rheumatology - Leiden University Medical Center - The Netherlands
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01061736     History of Changes
Other Study ID Numbers: EFC11072, 2009-016266-90
Study First Received: February 2, 2010
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014