Evaluation of SAR153191(REGN88)(Sarilumab) on Top of Methotrexate in Rheumatoid Arthritis Patients (RA-MOBILITY)
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01061736
First received: February 2, 2010
Last updated: November 14, 2012
Last verified: November 2012
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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 |
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 average change from baseline in HAQ-DI from Week 8 to Week 52 [ Time Frame: Week 52 ] [ 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 ]
| 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 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061736
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| United States, Alabama | |
| Investigational Site Number 840070 | |
| Anniston, Alabama, United States, 36207 | |
| Investigational Site Number 840004 | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Arizona | |
| Investigational Site Number 840072 | |
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| Vina Del Mar, Chile | |
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| Viña Del Mar, Chile, 2570017 | |
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| Barranquilla, Colombia | |
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| Bogota, Colombia | |
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| Bogota, Colombia | |
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| Bogotá, Colombia | |
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| Bogotá, Colombia | |
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| Bucaramanga, Colombia | |
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| Medellin, Colombia | |
| Czech Republic | |
| Investigational Site Number 203005 | |
| Brno, Czech Republic, 63801 | |
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| Hlucin, Czech Republic, 74801 | |
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| Praha 2, Czech Republic, 12850 | |
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| Uherske Hradiste, Czech Republic, 68601 | |
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| Investigational Site Number 818001 | |
| Cairo, Egypt | |
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| Cairo, Egypt | |
| Estonia | |
| Investigational Site Number 233001 | |
| Tallinn, Estonia, 10128 | |
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| Tallinn, Estonia, 13419 | |
| Finland | |
| Investigational Site Number 246001 | |
| Helsinki, Finland, 00290 | |
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| Hyvinkää, Finland, 05800 | |
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| Pori, Finland, 28100 | |
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| Berlin, Germany, 12161 | |
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| Berlin, Germany, 12161 | |
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| Erlangen, Germany, 91054 | |
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| Frankfurt Am Main, Germany, 60590 | |
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| Athens, Greece, 11527 | |
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| Heraklion, Greece, 71110 | |
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| Budapest, Hungary, 1027 | |
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| India | |
| Investigational Site Number 356015 | |
| Ahmedabad, India, 380009 | |
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| Bangalore, India, 560079 | |
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| Chennai, India, 600004 | |
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| Hyderabad, India, 500004 | |
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| Hyderabad, India, 500003 | |
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| Lucknow, India, 226014 | |
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| Lucknow, India, 226003 | |
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| Maharashtra, India, 411 001 | |
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| Mumbai, India, 400012 | |
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| New Delhi, India, 76 | |
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| New Delhi, India, 122001 | |
| Korea, Republic of | |
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| Anyang, Korea, Republic of, 431-070 | |
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| Busan, Korea, Republic of, 602-739 | |
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| Daegu, Korea, Republic of, 700-721 | |
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| Daegu, Korea, Republic of, 705-718 | |
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| Seoul, Korea, Republic of, 133-792 | |
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| Seoul, Korea, Republic of | |
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| Seoul, Korea, Republic of, 150-713 | |
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| Suwon, Korea, Republic of, 443-721 | |
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| Vilnius, Lithuania, LT-08661 | |
| Malaysia | |
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| Ipoh, Malaysia, 30990 | |
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| Kuching, Malaysia, 93586 | |
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| Putrajaya, Malaysia | |
| Mexico | |
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| Durango, Mexico, 34270 | |
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| Guadalajara, Mexico, 44690 | |
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| Merida, Mexico, 97000 | |
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| Merida, Mexico, 97000 | |
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| Metepec, Mexico, 52140 | |
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| Mexico City, Mexico, 6726 | |
| Investigational Site Number 484001 | |
| Mexico, D.F., Mexico, 11850 | |
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| Monterrey, Mexico, 64000 | |
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| Heerlen, Netherlands, 6419 PC | |
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| Christchurch, New Zealand, 8002 | |
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| Kristiansand, Norway, 4604 | |
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| Tønsberg, Norway, 3105 | |
| Philippines | |
| Investigational Site Number 608003 | |
| Cebu City, Philippines, 6000 | |
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| Manila, Philippines | |
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| Manila, Philippines, 1008 | |
| Poland | |
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| Bialystok, Poland, 15-461 | |
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| Bialystok, Poland, 15-354 | |
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| Krakow, Poland, 30-510 | |
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| Torun, Poland, 87-100 | |
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| Warszawa, Poland, 02-118 | |
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| Wroclaw, Poland, 50-044 | |
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| Aveiro, Portugal, 3814-501 | |
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| Lisboa, Portugal, 1649-035 | |
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| Lisboa, Portugal | |
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| Moscow, Russian Federation, 117997 | |
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| Moscow, Russian Federation, 115522 | |
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| Saint-Petersburg, Russian Federation, 196247 | |
| Investigational Site Number 643010 | |
| Samara, Russian Federation, 443095 | |
| Investigational Site Number 643011 | |
| Saratov, Russian Federation, 410053 | |
| Investigational Site Number 643007 | |
| St-Petersburg, Russian Federation, 190068 | |
| Investigational Site Number 643008 | |
| St-Petersburg, Russian Federation, 192242 | |
| Investigational Site Number 643013 | |
| Ufa, Russian Federation, 450005 | |
| South Africa | |
| Investigational Site Number 710009 | |
| Cape Town, South Africa, 8001 | |
| Investigational Site Number 710011 | |
| Cape Town, South Africa, 7405 | |
| Investigational Site Number 710007 | |
| Cape Town, South Africa, 7530 | |
| Investigational Site Number 710002 | |
| Durban, South Africa, 4091 | |
| Investigational Site Number 710003 | |
| Durban, South Africa, 4001 | |
| Investigational Site Number 710001 | |
| Johannesburg, South Africa, 2013 | |
| Investigational Site Number 710004 | |
| Kempton Park, South Africa, 1619 | |
| Investigational Site Number 710005 | |
| Pretoria, South Africa, 0075 | |
| Investigational Site Number 710006 | |
| Pretoria, South Africa, 0182 | |
| Investigational Site Number 710008 | |
| Pretoria, South Africa | |
| Investigational Site Number 710010 | |
| Stellenbosch, South Africa, 7600 | |
| Spain | |
| Investigational Site Number 724010 | |
| Barcelona, Spain, 08025 | |
| Investigational Site Number 724009 | |
| La Coruña, Spain, 15006 | |
| Investigational Site Number 724011 | |
| Sabadell, Spain, 08208 | |
| Investigational Site Number 724012 | |
| Santiago De Compostela, Spain, 15705 | |
| Investigational Site Number 724007 | |
| Sevilla, Spain, 41008 | |
| Taiwan | |
| Investigational Site Number 158002 | |
| Linkou, Taiwan, 333 | |
| Investigational Site Number 158001 | |
| Taipei, Taiwan, 100 | |
| Thailand | |
| Investigational Site Number 764003 | |
| Bangkok, Thailand, 10700 | |
| Investigational Site Number 764001 | |
| Bangkok, Thailand, 10400 | |
| Turkey | |
| Investigational Site Number 792003 | |
| Adana, Turkey, 01330 | |
| Investigational Site Number 792002 | |
| Ankara, Turkey, 06100 | |
| Investigational Site Number 792005 | |
| Ankara, Turkey | |
| Investigational Site Number 792004 | |
| Antalya, Turkey, 07059 | |
| Investigational Site Number 792001 | |
| Izmir, Turkey, 35340 | |
| Ukraine | |
| Investigational Site Number 804003 | |
| Dnipropetrovsk, Ukraine, 49008 | |
| Investigational Site Number 804002 | |
| Donetsk, Ukraine, 83114 | |
| Investigational Site Number 804010 | |
| Kharkov, Ukraine, 61022 | |
| Investigational Site Number 804004 | |
| Kyiv, Ukraine, 03151 | |
| Investigational Site Number 804008 | |
| Kyiv, Ukraine, 01023 | |
| Investigational Site Number 804005 | |
| Lviv, Ukraine, 79005 | |
| Investigational Site Number 804006 | |
| Simferopol, Ukraine, 95017 | |
| Investigational Site Number 804009 | |
| Zaporizhzhia, Ukraine, 69600 | |
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 |
| 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 19, 2013