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

  Hide Study Locations
Locations
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
Gilbert, Arizona, United States, 85234
United States, California
Investigational Site Number 840029
Beverly Hills, California, United States, 90211
Investigational Site Number 840007
Palm Desert, California, United States, 92260
Investigational Site Number 840008
San Francisco, California, United States, 94143
Investigational Site Number 840021
Santa Maria, California, United States, 94354
Investigational Site Number 840049
Upland, California, United States, 91786
United States, Florida
Investigational Site Number 840050
Dunedin, Florida, United States, 34698
Investigational Site Number 840041
Jacksonville, Florida, United States, 32209
Investigational Site Number 840067
Jupiter, Florida, United States, 33458
Investigational Site Number 840048
Miami, Florida, United States, 33155
Investigational Site Number 840006
Orlando, Florida, United States, 32806
Investigational Site Number 840063
Palm Harbor, Florida, United States, 34684
Investigational Site Number 840060
Sarasota, Florida, United States, 34239
United States, Georgia
Investigational Site Number 840003
Atlanta, Georgia, United States, 30322
Investigational Site Number 840028
Decatur, Georgia, United States, 30033
Investigational Site Number 840027
Marietta, Georgia, United States, 30060
United States, Idaho
Investigational Site Number 840018
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site Number 840046
Chicago, Illinois, United States, 60612
United States, Kentucky
Investigational Site Number 840015
Lexington, Kentucky, United States, 40504
United States, Maryland
Investigational Site Number 840073
Cumberland, Maryland, United States, 21502
Investigational Site Number 840055
Frederick, Maryland, United States, 21702
Investigational Site Number 840013
Wheaton, Maryland, United States, 20902
United States, Missouri
Investigational Site Number 840066
St. Louis, Missouri, United States, 63117
United States, Nebraska
Investigational Site Number 840071
Omaha, Nebraska, United States, 68114
United States, New York
Investigational Site Number 840056
New York, New York, United States, 10016
United States, North Carolina
Investigational Site Number 840068
Hickory, North Carolina, United States, 28601
United States, Ohio
Investigational Site Number 840044
Toledo, Ohio, United States, 43606
United States, Oklahoma
Investigational Site Number 840002
Oklahoma City, Oklahoma, United States, 73103
Investigational Site Number 840011
Tulsa, Oklahoma, United States, 74104
Investigational Site Number 840065
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Investigational Site Number 840010
Bethlehem, Pennsylvania, United States, 18015
Investigational Site Number 840009
Duncansville, Pennsylvania, United States, 16635
Investigational Site Number 840062
Reading, Pennsylvania, United States, 19611
United States, South Carolina
Investigational Site Number 840058
Columbia, South Carolina, United States, 29204
Investigational Site Number 840016
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Investigational Site Number 840025
Jackson, Tennessee, United States, 38305
United States, Texas
Investigational Site Number 840001
Dallas, Texas, United States, 75231
Investigational Site Number 840022
Dallas, Texas, United States, 75235
Investigational Site Number 840012
Dallas, Texas, United States, 75390
Investigational Site Number 840020
Houston, Texas, United States, 77034
Investigational Site Number 840069
Lubbock, Texas, United States, 79424
Investigational Site Number 840074
Mesquite, Texas, United States, 75150
United States, Washington
Investigational Site Number 840061
Tacoma, Washington, United States, 98405
Argentina
Investigational Site Number 032005
Buenos Aires, Argentina, 4000
Investigational Site Number 032008
Buenos Aires, Argentina
Investigational Site Number 032007
Buenos Aires, Argentina
Investigational Site Number 032006
Caba, Argentina, C1015ABO
Investigational Site Number 032002
Cordoba, Argentina, X5004BAL
Investigational Site Number 032003
Córdoba, Argentina
Investigational Site Number 032012
Mar Del Plata, Argentina, B7600
Investigational Site Number 032011
Quilmes, Argentina, B1878DVB
Investigational Site Number 032010
Ramos Mejia, Argentina, 1704
Investigational Site Number 032001
Rosario, Argentina, 2000
Investigational Site Number 032004
Tucuman, Argentina, 4000
Investigational Site Number 032009
Zarate, Argentina, 2800
Australia
Investigational Site Number 036003
Camperdown, Australia, 2050
Investigational Site Number 036005
Clayton, Australia, 3168
Investigational Site Number 036002
East Malvern, Australia, 3145
Investigational Site Number 036012
Fitzroy, Australia, 3065
Investigational Site Number 036010
Garran, Australia, 2605
Investigational Site Number 036004
Heidelberg West, Australia, 3081
Investigational Site Number 036009
Herston, Australia, 4029
Investigational Site Number 036001
Maroochydore, Australia, 4558
Investigational Site Number 036006
St Leonards, Australia, 2065
Investigational Site Number 036011
Sydney, Australia, 2035
Investigational Site Number 036014
Victoria Park, Australia, 6100
Investigational Site Number 036007
Woodville, Australia, 5011
Austria
Investigational Site Number 040001
Graz, Austria, 8036
Investigational Site Number 040002
Wien, Austria, 1100
Belarus
Investigational Site Number 112001
Minsk, Belarus, 220116
Investigational Site Number 112002
Minsk, Belarus, 220037
Belgium
Investigational Site Number 056003
Genk, Belgium, 3600
Investigational Site Number 056001
Liège, Belgium, 4000
Brazil
Investigational Site Number 076008
Campinas, Brazil, 13015-001
Investigational Site Number 076012
Campinas, Brazil, 13083-970
Investigational Site Number 076001
Curitiba, Brazil, 80060-240
Investigational Site Number 076006
Goiania, Brazil, 74110-120
Investigational Site Number 076010
Juiz De Fora, Brazil, 36010-570
Investigational Site Number 076004
Porto Alegre, Brazil, 90610-000
Investigational Site Number 076005
Rio De Janeiro, Brazil, 20551-030
Investigational Site Number 076011
Salvador, Brazil, 40050-410
Investigational Site Number 076003
Sao Paulo, Brazil, 04230 000
Investigational Site Number 076002
Sao Paulo, Brazil, 04039-901
Investigational Site Number 076013
Vitoria, Brazil, 29055 450
Canada
Investigational Site Number 124004
Burlington, Canada, L7R 1E2
Investigational Site Number 124003
Mississauga, Canada, L5M 2V8
Investigational Site Number 124008
Newmarket, Canada, L3Y 3R7
Investigational Site Number 124002
St. Catharines, Canada, L2N 7E4
Investigational Site Number 124005
Toronto, Canada, M5T 2S8
Investigational Site Number 124001
Toronto, Canada, M9R 2Y8
Investigational Site Number 124012
Winnipeg, Canada, R3A 1M3
Chile
Investigational Site Number 152005
Osorno, Chile
Investigational Site Number 152010
Puerto Montt, Chile
Investigational Site Number 152008
Santiago, Chile
Investigational Site Number 152012
Santiago, Chile, 7500922
Investigational Site Number 152001
Santiago, Chile
Investigational Site Number 152002
Santiago, Chile
Investigational Site Number 152009
Santiago, Chile
Investigational Site Number 152013
Santiago, Chile
Investigational Site Number 152011
Santiago, Chile
Investigational Site Number 152014
Talca, Chile, 3460000
Investigational Site Number 152004
Valdivia, Chile
Investigational Site Number 152006
Vina Del Mar, Chile
Investigational Site Number 152007
Viña Del Mar, Chile, 2570017
Colombia
Investigational Site Number 170004
Barranquilla, Colombia
Investigational Site Number 170008
Bogota, Colombia
Investigational Site Number 170001
Bogota, Colombia
Investigational Site Number 170003
Bogotá, Colombia
Investigational Site Number 170006
Bogotá, Colombia
Investigational Site Number 170007
Bucaramanga, Colombia
Investigational Site Number 170009
Bucaramanga, Colombia
Investigational Site Number 170002
Medellin, Colombia
Czech Republic
Investigational Site Number 203005
Brno, Czech Republic, 63801
Investigational Site Number 203004
Hlucin, Czech Republic, 74801
Investigational Site Number 203001
Praha 2, Czech Republic, 12850
Investigational Site Number 203002
Uherske Hradiste, Czech Republic, 68601
Egypt
Investigational Site Number 818001
Cairo, Egypt
Investigational Site Number 818002
Cairo, Egypt
Estonia
Investigational Site Number 233001
Tallinn, Estonia, 10128
Investigational Site Number 233002
Tallinn, Estonia, 13419
Finland
Investigational Site Number 246001
Helsinki, Finland, 00290
Investigational Site Number 246002
Hyvinkää, Finland, 05800
Investigational Site Number 246003
Pori, Finland, 28100
Germany
Investigational Site Number 276008
Berlin, Germany, 12161
Investigational Site Number 276007
Berlin, Germany, 12161
Investigational Site Number 276004
Erlangen, Germany, 91054
Investigational Site Number 276003
Frankfurt Am Main, Germany, 60590
Investigational Site Number 276015
Halle/Saale, Germany, 06108
Investigational Site Number 276005
Hamburg, Germany, 22081
Investigational Site Number 276013
Hamburg, Germany, 22147
Investigational Site Number 276012
Heidelberg, Germany, 69120
Investigational Site Number 276001
Herne, Germany, 44652
Investigational Site Number 276006
Hildesheim, Germany, 31134
Greece
Investigational Site Number 300001
Athens, Greece, 11527
Investigational Site Number 300002
Heraklion, Greece, 71110
Investigational Site Number 300003
Thessaloniki, Greece, 546 36
Hungary
Investigational Site Number 348006
Budapest, Hungary, 1023
Investigational Site Number 348014
Budapest, Hungary, 1027
Investigational Site Number 348003
Debrecen, Hungary, 4032
Investigational Site Number 348010
Debrecen, Hungary, 4043
Investigational Site Number 348011
Eger, Hungary, 3300
Investigational Site Number 348013
Gy?r, Hungary, 9025
Investigational Site Number 348015
Szombathely, Hungary, H-9700
Investigational Site Number 348005
Sátoraljaújhely, Hungary, 3980
Investigational Site Number 348004
Veszprém, Hungary, 8200
India
Investigational Site Number 356015
Ahmedabad, India, 380009
Investigational Site Number 356007
Bangalore, India, 560079
Investigational Site Number 356003
Chennai, India, 600004
Investigational Site Number 356005
Hyderabad, India, 500004
Investigational Site Number 356012
Hyderabad, India, 500003
Investigational Site Number 356013
Lucknow, India, 226014
Investigational Site Number 356011
Lucknow, India, 226003
Investigational Site Number 356001
Maharashtra, India, 411 001
Investigational Site Number 356004
Mumbai, India, 400012
Investigational Site Number 356010
Mumbai, India, 400008
Investigational Site Number 356008
New Delhi, India, 76
Investigational Site Number 356002
New Delhi, India, 122001
Korea, Republic of
Investigational Site Number 410014
Anyang, Korea, Republic of, 431-070
Investigational Site Number 410006
Busan, Korea, Republic of, 602-739
Investigational Site Number 410004
Daegu, Korea, Republic of, 700-721
Investigational Site Number 410013
Daegu, Korea, Republic of, 705-718
Investigational Site Number 410005
Daejeon, Korea, Republic of, 302-799
Investigational Site Number 410010
Gwangju, Korea, Republic of, 501-757
Investigational Site Number 410009
Incheon, Korea, Republic of, 400-711
Investigational Site Number 410001
Incheon, Korea, Republic of
Investigational Site Number 410011
Jeonju, Korea, Republic of, 561-712
Investigational Site Number 410012
Seoul, Korea, Republic of, 133-792
Investigational Site Number 410002
Seoul, Korea, Republic of
Investigational Site Number 410003
Seoul, Korea, Republic of, 150-713
Investigational Site Number 410007
Seoul, Korea, Republic of, 110-744
Investigational Site Number 410008
Suwon, Korea, Republic of, 443-721
Lithuania
Investigational Site Number 440001
Kaunas, Lithuania, LT-50009
Investigational Site Number 440002
Vilnius, Lithuania, LT-08661
Malaysia
Investigational Site Number 458001
Ipoh, Malaysia, 30990
Investigational Site Number 458002
Kuching, Malaysia, 93586
Investigational Site Number 458003
Putrajaya, Malaysia
Mexico
Investigational Site Number 484008
Durango, Mexico, 34270
Investigational Site Number 484002
Guadalajara, Mexico, 44690
Investigational Site Number 484004
Merida, Mexico, 97000
Investigational Site Number 484009
Merida, Mexico, 97000
Investigational Site Number 484007
Metepec, Mexico, 52140
Investigational Site Number 484003
Mexico City, Mexico, 6726
Investigational Site Number 484001
Mexico, D.F., Mexico, 11850
Investigational Site Number 484005
Monterrey, Mexico, 64000
Netherlands
Investigational Site Number 528002
Heerlen, Netherlands, 6419 PC
New Zealand
Investigational Site Number 554004
Christchurch, New Zealand, 8002
Investigational Site Number 554002
Rotorua, New Zealand
Investigational Site Number 554003
Tauranga, New Zealand, 3001
Investigational Site Number 554001
Timaru, New Zealand
Norway
Investigational Site Number 578004
Kristiansand, Norway, 4604
Investigational Site Number 578006
Tønsberg, Norway, 3105
Philippines
Investigational Site Number 608003
Cebu City, Philippines, 6000
Investigational Site Number 608002
Manila, Philippines
Investigational Site Number 608001
Manila, Philippines, 1008
Poland
Investigational Site Number 616003
Bialystok, Poland, 15-461
Investigational Site Number 616002
Bialystok, Poland, 15-354
Investigational Site Number 616001
Krakow, Poland, 30-510
Investigational Site Number 616005
Lublin, Poland, 20-607
Investigational Site Number 616006
Torun, Poland, 87-100
Investigational Site Number 616004
Warszawa, Poland, 02-118
Investigational Site Number 616012
Wroclaw, Poland, 50-044
Portugal
Investigational Site Number 620003
Aveiro, Portugal, 3814-501
Investigational Site Number 620001
Lisboa, Portugal, 1649-035
Investigational Site Number 620002
Lisboa, Portugal
Romania
Investigational Site Number 642006
Braila, Romania, 810019
Investigational Site Number 642004
Bucharest, Romania
Investigational Site Number 642010
Bucharest, Romania
Investigational Site Number 642003
Bucuresti, Romania, 400347
Investigational Site Number 642001
Bucuresti, Romania, 010976
Investigational Site Number 642002
Bucuresti, Romania, 020983
Investigational Site Number 642005
Galati, Romania, 800578
Investigational Site Number 642008
Ploiesti, Romania
Russian Federation
Investigational Site Number 643006
Kemerovo, Russian Federation, 650099
Investigational Site Number 643017
Kemerovo, Russian Federation, 650066
Investigational Site Number 643002
Moscow, Russian Federation, 117997
Investigational Site Number 643001
Moscow, Russian Federation, 115522
Investigational Site Number 643020
Moscow, Russian Federation, 115404
Investigational Site Number 643004
Moscow, Russian Federation, 107014
Investigational Site Number 643012
Moscow, Russian Federation, 121359
Investigational Site Number 643009
Novosibirsk, Russian Federation, 630099
Investigational Site Number 643016
Ryazan, Russian Federation, 390026
Investigational Site Number 643014
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, 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 August 28, 2014