Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

• Register: EUCTR
• Last refreshed on: 28 August 2014
• Main ID: EUCTR2009-016266-90-EE
• Date of registration: 05/01/2010
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients
• Scientific 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 - MOBILITY
• Date of first enrolment: 02/03/2010
• Target sample size: 1594
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016266-90
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, Estonia, Finland, Germany, Greece, Hungary, India, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Clinical Study Unit
• Affiliation: sanofi-aventis Estonia OÜ

• Name: Clinical Study Unit
• Affiliation: sanofi-aventis Estonia OÜ

Key inclusion & exclusion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1403
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 191

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Sarilumab
Product Code: SAR153191
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Sarilumab
Product Code: SAR153191
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 87.7-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Sarilumab
Product Code: SAR153191
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Sar

Primary Outcome(s)

Primary end point(s): Part A:
Percentage of patients who achieved American College of Rheumatology criteria for improvement ACR20
Part B:
- ACR20 response at Week 24
- Change in modified Van der Heijde total Sharp score at Week 52
- Change in physical function as measured by the average change from
baseline in the Health Assessment Question-Disability (HAQ-DI) from
Week 8 to Week 52

Timepoint(s) of evaluation of this end point: Part A: at week 12
Part B: at week 24 and week 52

Main Objective: Part A:
To demonstrate that SAR153191 (REGN88) on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks
Part B:
To demonstrate that sarilumab 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 Objective: To demonstrate that sarilumab added to MTX is effective in induction of
a major clinical response at 52 weeks
To assess the safety of sarilumab added to MTX
To document the pharmacokinetic profile of sarilumab added to MTX, in
patients with active rheumatoid arthritis who are inadequate responders
to MTX therapy.

Secondary Outcome(s)

Secondary end point(s): Part B: Major clinical response defined as the event of achieving and
maintaining an ACR 70 response (for at least 24 weeks).

Timepoint(s) of evaluation of this end point: Week 52 for all above mentioned secondary endpoints

Secondary ID(s)

2009-016266-90-ES

EFC11072