Trial Outcomes & Findings for Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers (NCT NCT01217814)
NCT ID: NCT01217814
Last Updated: 2017-09-01
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Week 12
Results posted on
2017-09-01
Participant Flow
The study was conducted at 10 centers in United States and Europe. A total of 41 participants were screened between 15 November 2010 and 18 May 2011 of whom 16 participants were randomized and 25 were screen failures. Screen failures were mainly due to exclusion criteria met.
Participants were randomized 2:1:2 (Sarilumab 150 mg : Placebo : Golimumab 50 mg) via a centralized randomization system using an interactive voice response system stratified by region and number of previous anti-tumor necrosis factor-alpha (TNF-α) therapy.
Participant milestones
| Measure |
Placebo
Subcutaneous (SC) injection of placebo 2 mL once a week (qw) to match sarilumab and 0.5 mL every 4 weeks (q4w) to match golimumab on top of methotrexate (MTX) (15-25 mg) qw for 12 weeks.
|
Golimumab 50 mg
Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
|
Sarilumab 150 mg
Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
7
|
|
Overall Study
COMPLETED
|
3
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Subcutaneous (SC) injection of placebo 2 mL once a week (qw) to match sarilumab and 0.5 mL every 4 weeks (q4w) to match golimumab on top of methotrexate (MTX) (15-25 mg) qw for 12 weeks.
|
Golimumab 50 mg
Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
|
Sarilumab 150 mg
Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
Baseline Characteristics
Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
|
Golimumab 50 mg
n=5 Participants
Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
|
Sarilumab 150 mg
n=7 Participants
Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 17.9 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
54.0 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
54.5 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed in PK population of all participants with at least one non-missing serum concentration data.
Outcome measures
| Measure |
Placebo
n=7 Participants
SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
|
Golimumab 50 mg
Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
|
Sarilumab 150 mg
Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
|
|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab
Bound Concentration
|
4271.43 ng/mL
Standard Deviation 1328.86
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab
Functional Concentration
|
42391.43 ng/mL
Standard Deviation 26168.68
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Golimumab 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sarilumab 150 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
SC injection of placebo 2 mL qw to match sarilumab and 0.5 mL q4w to match golimumab on top of MTX (15-25 mg) qw for 12 weeks.
|
Golimumab 50 mg
n=5 participants at risk
Golimumab 50 mg SC injection q4w and placebo (matched to sarilumab) SC injection qw on top of MTX (15-25 mg) qw for 12 weeks.
|
Sarilumab 150 mg
n=7 participants at risk
Sarilumab 150 mg SC injection qw and placebo (matched to golimumab) SC injection q4w on top of MTX (15-25 mg) qw for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
20.0%
1/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
20.0%
1/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
20.0%
1/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
General disorders
Application site reaction
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
General disorders
Chills
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
25.0%
1/4 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
0.00%
0/5 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (week 18) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of the double-blind investigational product to the end of the follow-up period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER