Evaluation of SAR153191(REGN88)(Sarilumab) on Top of Methotrexate in Rheumatoid Arthritis Patients (RA-MOBILITY)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 over 52 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 |
- 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 average change from baseline in HAQ-DI from Week 8 to Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 1594 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated 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 |
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
Show 262 Study Locations| 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 |
| Study First Received: | February 2, 2010 |
| Last Updated: | November 14, 2012 |
| 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 May 16, 2013