Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis (ALIGN)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Primary objective:
- to evaluate the efficacy of Sarilumab in patients with Ankylosing Spondylitis [AS] using the Assessment in AS working group criteria [ASAS] 20% response criteria [ASAS20]
Secondary objectives:
to demonstrate that Sarilumab is effective on:
- assessment of higher level of response (ASAS 40% response criteria [ASAS40])
- partial remission
- disease activity
- range of motion
- Magnetic Resonance Imaging [MRI] of the spine
- to assess the safety and tolerability of Sarilumab in patients with AS as well as the pharmacokinetic profile of Sarilumab in patients with AS
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: Sarilumab Drug: placebo |
Phase 2 |
| 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 Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Patients With Ankylosing Spondylitis (AS) |
- Percentage of participants who achieve a 20% response according to the Assessment in AS Working Group Criteria for response [ASAS20] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percentage of participants who achieve a 40% response according to the Assessment in AS Working Group Criteria for response [ASAS40] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percentage of participants who achieve partial remission according to the Assessment in AS Working Group Criteria for response [ASAS] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in disease activity assessed by the Ankylosing Spondylitis Disease Activity Score [ASDAS] [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in disease activity assessed the Bath AS Disease Activity Index [BASDAI] [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in range of motion assessed by the Bath AS Metrology Index [BASMI] [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Magnetic Resonance Imaging [MRI] score of the spine assessed by The Berlin modification of the AS spine MRI-active [ASspiMRI-a] scoring system [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Percentage of participants who achieve ASAS 5/6 improvement criteria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Chest Expansion [ Time Frame: Baselin an 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Swollen Joint Index [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in high sensitive C-Reactive Protein [hs-CRP] [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in ASAS components [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 301 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sarilumab 100mg weekly
Single injection of 2 mL of Sarilumab 50 mg/mL once a week for 12 weeks
|
Drug: Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Names:
|
|
Experimental: Sarilumab 150mg weekly
Single injection of 2 mL of Sarilumab 75 mg/mL once a week for 12 weeks
|
Drug: Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Names:
|
|
Experimental: Sarilumab 100mg every other week
Single injection of 2 mL of Sarilumab 50 mg/mL every other week for 12 weeks alternating with placebo
|
Drug: Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Names:
Drug: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
Experimental: Sarilumab 150mg every other week
Single injection of 2 mL of Sarilumab 75 mg/mL every other week for 12 weeks alternating with placebo
|
Drug: Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Names:
Drug: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
Experimental: Sarilumab 200mg every other week
Single injection of 2 mL of Sarilumab 100 mg/mL every other week for 12 weeks alternating with placebo
|
Drug: Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Names:
Drug: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
Placebo Comparator: placebo
Single injection of 2 mL of placebo once a week for 12 weeks
|
Drug: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous |
Detailed Description:
The duration of participation in this study for each patient was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Diagnosis AS according to the New York modified criteria
- Patient must have an adequate trial of at least 2 different Non Steroidal Anti-Inflammatory Drugs [NSAIDs] taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to NSAIDs
Patient must have active AS for ≥3 months before screening and active disease must be present at screening and at baseline; Active AS being defined by:
- Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score of ≥4 (Numerical Rating Scale 0-10)
- Total back pain score ≥4 (Numerical Rating Scale 0-10)
Patients treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline
Patients treated with the Disease Modifying Anti-Rheumatic Drugs [DMARDs] hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose ≥12 weeks prior to baseline
Exclusion criteria:
- <18 years old or ≥75 years old
- Complete fusion of the spine
- Past history of non response to any anti-Tumor Necrosis Factors [TNFs] treatment or non response to any other biological treatment for AS
- Any past or current treatment with anti-TNF's or any biological agent within 3 months prior to screening
- Treatment with DMARDs except for hydroxychloroquine, sulfasalazine and MTX
- MTX >25 mg/week
- hydroxychloroquine >400 mg/day
- Sulfasalazine >3 g/day
- Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within 6 weeks prior to screening
- Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening
- Previous treatment with cyclosporine, azathioprine
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Show 80 Study Locations| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01061723 History of Changes |
| Other Study ID Numbers: | DRI11073, 2009-016068-35 |
| Study First Received: | February 2, 2010 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases |
Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis |
ClinicalTrials.gov processed this record on May 19, 2013