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
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 April 17, 2014