Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis (ALIGN)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01061723
First received: February 2, 2010
Last updated: August 2, 2012
Last verified: August 2012
  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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • SAR153191
  • REGN88
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:
  • SAR153191
  • REGN88
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:
  • SAR153191
  • REGN88
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:
  • SAR153191
  • REGN88
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:
  • SAR153191
  • REGN88
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
Criteria

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
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: NCT01061723

  Show 80 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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 September 16, 2014