An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
Status: | Terminated |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2013 |
End Date: | January 2015 |
A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX
Primary Objective:
To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to
etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an
inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity
Score for 28 joints (DAS28).
Secondary Objectives:
To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab
in combination with methotrexate (MTX).
To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in
combination with methotrexate (MTX).
To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in
patients with rheumatoid arthritis (RA).
To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to
etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an
inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity
Score for 28 joints (DAS28).
Secondary Objectives:
To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab
in combination with methotrexate (MTX).
To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in
combination with methotrexate (MTX).
To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in
patients with rheumatoid arthritis (RA).
The maximum study duration per patient enrolled in the Main study is 54 weeks broken down as
follows:
- screening/run-in up to a maximum of 24 weeks
- treatment up to a maximum of 24 weeks
- follow-up of 6 weeks after treatment discontinuation.
The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as
follows:
- treatment up to a maximum of 52 weeks
- follow-up of 6 weeks after treatment discontinuation.
follows:
- screening/run-in up to a maximum of 24 weeks
- treatment up to a maximum of 24 weeks
- follow-up of 6 weeks after treatment discontinuation.
The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as
follows:
- treatment up to a maximum of 52 weeks
- follow-up of 6 weeks after treatment discontinuation.
Inclusion criteria:
- Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.
- Continuous treatment of methotrexate (MTX) 10 - 25 mg/week (or per local labeling
requirements if the dose range differs) for at least 12 weeks before screening visit
and on a stable dose for 8 weeks before screening visit.
- Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high
sensitivity C-reactive protein > 10 mg/L.
Exclusion criteria:
- Age < 18 years.
- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
of the screening visit.
- Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per
day, or a change in dosage within 4 weeks of the screening visit.
- Prior treatment with a TNF (tumor necrosis factor)-alpha inhibitor, or other
biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
- New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory
drugs (NSAIDs) or cyclo-oxygenase-2 inhibitors (COX-2 inhibitors within 4 weeks of
the screening visit.
- Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD)
/immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the
screening visit, depending on DMARD.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
31
sites
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