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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01061723




Registration number
NCT01061723
Ethics application status
Date submitted
2/02/2010
Date registered
3/02/2010
Date last updated
8/08/2017

Titles & IDs
Public title
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Scientific title
A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)
Secondary ID [1] 0 0
2009-016068-35
Secondary ID [2] 0 0
DRI11073
Universal Trial Number (UTN)
Trial acronym
ALIGN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sarilumab
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Placebo (for sarilumab) weekly (qw) for 12 weeks.

Experimental: Sarilumab 100 mg q2w - Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks.

Experimental: Sarilumab 150 mg q2w - Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.

Experimental: Sarilumab 100 mg qw - Sarilumab 100 mg SC injection qw for 12 weeks.

Experimental: Sarilumab 200 mg q2w - Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.

Experimental: Sarilumab 150 mg qw - Sarilumab 150 mg SC injection qw for 12 weeks.


Treatment: Drugs: Sarilumab
Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12
Timepoint [1] 0 0
Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12
Timepoint [1] 0 0
Baseline to Week 12 (LOCF)
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12
Timepoint [2] 0 0
Baseline to Week 12 (LOCF)
Secondary outcome [3] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
Timepoint [3] 0 0
Baseline, Week 12 (LOCF)
Secondary outcome [4] 0 0
Change From Baseline in BASDAI Score at Week 12
Timepoint [4] 0 0
Baseline, Week 12 (LOCF)
Secondary outcome [5] 0 0
Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12
Timepoint [5] 0 0
Baseline, Week 12 (LOCF)
Secondary outcome [6] 0 0
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) Score at Week 12
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12
Timepoint [7] 0 0
Baseline to Week 12 (LOCF)
Secondary outcome [8] 0 0
Change From Baseline in Chest Expansion at Week 12
Timepoint [8] 0 0
Baseline, Week 12 (LOCF)
Secondary outcome [9] 0 0
Change From Baseline in Swollen Joint Index at Week 12
Timepoint [9] 0 0
Baseline, Week 12 (LOCF)
Secondary outcome [10] 0 0
Change From Baseline in Hs-CRP at Week 12
Timepoint [10] 0 0
Baseline, Week 12 (LOCF)
Secondary outcome [11] 0 0
Change From Baseline in ASAS Individual Components at Week 12
Timepoint [11] 0 0
Baseline, Week 12 (LOCF)

Eligibility
Key inclusion criteria
Inclusion criteria:

* Diagnosis of AS according to the New York modified criteria
* Participants must had 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
* Participants must had 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)

Participants treated with corticosteroid must be on a stable dose for =2 weeks prior to baseline

Participants treated with the Disease Modifying Anti-Rheumatic Drugs (DMARDs) hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose =12 weeks prior to baseline
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
301
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036001 - East Malvern
Recruitment hospital [2] 0 0
Investigational Site Number 036003 - Hobart
Recruitment hospital [3] 0 0
Investigational Site Number 036004 - Shenton Park
Recruitment hospital [4] 0 0
Investigational Site Number 036002 - Woolloongabba
Recruitment postcode(s) [1] 0 0
3145 - East Malvern
Recruitment postcode(s) [2] 0 0
7001 - Hobart
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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Florida
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Idaho
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Illinois
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Kansas
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Maryland
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Massachusetts
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Michigan
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Missouri
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New Jersey
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New York
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Oklahoma
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Pennsylvania
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Texas
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Virginia
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Austria
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Graz
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Wien
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Brussels
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Belgium
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Genk
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Gent
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Leuven
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Liège
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Hlucin
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Czechia
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Uherske Hradiste
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Besancon
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Frankfurt Am Main
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Hamburg
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Herne
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Hungary
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Budapest
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Hungary
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Debrecen
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Sátoraljaújhely
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Hungary
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Veszprém
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Netherlands
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Amsterdam
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Netherlands
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Nijmegen
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Bialystok
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Lublin
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Sevilla
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Turkey
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Ankara
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Turkey
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Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Sieper J, Braun J, Kay J, Badalamenti S, Radin AR,... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01061723