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

Ankylosing Spondylitis Clinical Trial

— ALIGN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061723
• Other study ID #: DRI11073
• Secondary ID: 2009-016068-35
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2010
• Last updated: August 2, 2012
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Australia	Investigational Site Number 036001	East Malvern
Australia	Investigational Site Number 036003	Hobart
Australia	Investigational Site Number 036004	Shenton Park
Australia	Investigational Site Number 036002	Woolloongabba
Austria	Investigational Site Number 040001	Graz
Austria	Investigational Site Number 040002	Wien
Belgium	Investigational Site Number 056003	Brussels
Belgium	Investigational Site Number 056005	Genk
Belgium	Investigational Site Number 056001	Gent
Belgium	Investigational Site Number 056002	Leuven
Belgium	Investigational Site Number 056004	Liège
Canada	Investigational Site Number 124007	London
Canada	Investigational Site Number 124004	Montreal
Canada	Investigational Site Number 124008	Newmarket
Canada	Investigational Site Number 124003	Pointe-Claire
Canada	Investigational Site Number 124001	Quebec
Canada	Investigational Site Number 124006	Saskatoon
Canada	Investigational Site Number 124005	Toronto
Canada	Investigational Site Number 124009	Trois-Rivières
Canada	Investigational Site Number 124002	Vancouver
Canada	Investigational Site Number 124010	Vancouver
Czech Republic	Investigational Site Number 203003	Brno
Czech Republic	Investigational Site Number 203005	Hlucin
Czech Republic	Investigational Site Number 203002	Hradec Kralove
Czech Republic	Investigational Site Number 203001	Praha 2
Czech Republic	Investigational Site Number 203004	Uherske Hradiste
France	Investigational Site Number 250001	Besancon
France	Investigational Site Number 250005	Bordeaux
France	Investigational Site Number 250002	Creteil Cedex
France	Investigational Site Number 250003	Paris
Germany	Investigational Site Number 276002	Berlin
Germany	Investigational Site Number 276004	Erlangen
Germany	Investigational Site Number 276003	Frankfurt Am Main
Germany	Investigational Site Number 276005	Hamburg
Germany	Investigational Site Number 276001	Herne
Hungary	Investigational Site Number 348001	Budapest
Hungary	Investigational Site Number 348003	Debrecen
Hungary	Investigational Site Number 348005	Sátoraljaújhely
Hungary	Investigational Site Number 348004	Veszprém
Lithuania	Investigational Site Number 440001	Kaunas
Lithuania	Investigational Site Number 440002	Vilnius
Netherlands	Investigational Site Number 528001	Amsterdam
Netherlands	Investigational Site Number 528002	Nijmegen
Poland	Investigational Site Number 616002	Bialystok
Poland	Investigational Site Number 616001	Krakow
Poland	Investigational Site Number 616004	Lublin
Poland	Investigational Site Number 616005	Torun
Poland	Investigational Site Number 616003	Warszawa
Spain	Investigational Site Number 724005	Barcelona
Spain	Investigational Site Number 724004	La Coruña
Spain	Investigational Site Number 724002	Madrid
Spain	Investigational Site Number 724001	Sevilla
Turkey	Investigational Site Number 792002	Ankara
Turkey	Investigational Site Number 792001	Izmir
United States	Investigational Site Number 840016	Albany	New York
United States	Investigational Site Number 840033	Anaheim	California
United States	Investigational Site Number 840023	Bethlehem	Pennsylvania
United States	Investigational Site Number 840006	Birmingham	Alabama
United States	Investigational Site Number 840009	Boca Raton	Florida
United States	Investigational Site Number 840015	Boise	Idaho
United States	Investigational Site Number 840034	Chesapeake	Virginia
United States	Investigational Site Number 840004	Dallas	Texas
United States	Investigational Site Number 840014	Duncansville	Pennsylvania
United States	Investigational Site Number 840028	Freehold	New Jersey
United States	Investigational Site Number 840030	Houston	Texas
United States	Investigational Site Number 840018	Kansas City	Kansas
United States	Investigational Site Number 840008	Lansing	Michigan
United States	Investigational Site Number 840027	Los Angeles	California
United States	Investigational Site Number 840001	Naples	Florida
United States	Investigational Site Number 840005	Oklahoma City	Oklahoma
United States	Investigational Site Number 840032	Orlando	Florida
United States	Investigational Site Number 840021	Rock Island	Illinois
United States	Investigational Site Number 840007	San Diego	California
United States	Investigational Site Number 840013	San Francisco	California
United States	Investigational Site Number 840002	St Louis	Missouri
United States	Investigational Site Number 840036	Syracuse	New York
United States	Investigational Site Number 840010	Toledo	Ohio
United States	Investigational Site Number 840017	Upland	California
United States	Investigational Site Number 840003	Wheaton	Maryland
United States	Investigational Site Number 840029	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Lithuania,  Netherlands,  Poland,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who achieve a 20% response according to the Assessment in AS Working Group Criteria for response [ASAS20]		12 weeks	No
Secondary	Percentage of participants who achieve a 40% response according to the Assessment in AS Working Group Criteria for response [ASAS40]		12 weeks	No
Secondary	Percentage of participants who achieve partial remission according to the Assessment in AS Working Group Criteria for response [ASAS]		12 weeks	No
Secondary	Change from baseline in disease activity assessed by the Ankylosing Spondylitis Disease Activity Score [ASDAS]		Baseline and 12 weeks	No
Secondary	Change from baseline in disease activity assessed the Bath AS Disease Activity Index [BASDAI]		Baseline and 12 weeks	No
Secondary	Change from baseline in range of motion assessed by the Bath AS Metrology Index [BASMI]		Baseline and 12 weeks	No
Secondary	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		Baseline and 12 weeks	No
Secondary	Percentage of participants who achieve ASAS 5/6 improvement criteria		12 weeks	No
Secondary	Change from baseline in Chest Expansion		Baselin an 12 weeks	No
Secondary	Change from baseline in Swollen Joint Index		Baseline and 12 weeks	No
Secondary	Change from baseline in high sensitive C-Reactive Protein [hs-CRP]		Baseline and 12 weeks	No
Secondary	Change from baseline in ASAS components		Baseline and 12 months	No