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

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Sarilumab

Placebo

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Sarilumab 100 mg q2w

Sarilumab 150 mg q2w

Sarilumab 100 mg qw

Sarilumab 200 mg q2w

Sarilumab 150 mg qw

Arm Description

Placebo (for sarilumab) weekly (qw) for 12 weeks.

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

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

Sarilumab 100 mg SC injection qw for 12 weeks.

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

Sarilumab 150 mg SC injection qw for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12

Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.

Secondary Outcome Measures

Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12

Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain.

Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12

Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] - 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).

Change From Baseline in BASDAI Score at Week 12

BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.

Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12

The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober's test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement.

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

ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation.

Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12

ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant.

Change From Baseline in Chest Expansion at Week 12

The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.

Change From Baseline in Swollen Joint Index at Week 12

44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.

Change From Baseline in Hs-CRP at Week 12

Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation.

Change From Baseline in ASAS Individual Components at Week 12

ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning.

Full Information

NCT ID

NCT01061723

First Posted

February 2, 2010

Last Updated

July 7, 2017

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01061723

Brief Title

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

Acronym

ALIGN

Official Title

A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: to demonstrate that Sarilumab was 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 participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

Detailed Description

The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (for sarilumab) weekly (qw) for 12 weeks.

Arm Title

Sarilumab 100 mg q2w

Arm Type

Experimental

Arm Description

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

Arm Title

Sarilumab 150 mg q2w

Arm Type

Experimental

Arm Description

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

Arm Title

Sarilumab 100 mg qw

Arm Type

Experimental

Arm Description

Sarilumab 100 mg SC injection qw for 12 weeks.

Arm Title

Sarilumab 200 mg q2w

Arm Type

Experimental

Arm Description

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

Arm Title

Sarilumab 150 mg qw

Arm Type

Experimental

Arm Description

Sarilumab 150 mg SC injection qw for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Sarilumab

Other Intervention Name(s)

SAR153191, REGN88

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12

Description

Time Frame

Baseline to Week 12 (Last Observation Carried Forward [LOCF])

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12

Description

Time Frame

Baseline to Week 12 (LOCF)

Title

Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12

Description

Time Frame

Baseline to Week 12 (LOCF)

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

Description

Time Frame

Baseline, Week 12 (LOCF)

Title

Change From Baseline in BASDAI Score at Week 12

Description

Time Frame

Baseline, Week 12 (LOCF)

Title

Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12

Description

Time Frame

Baseline, Week 12 (LOCF)

Title

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

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12

Description

Time Frame

Baseline to Week 12 (LOCF)

Title

Change From Baseline in Chest Expansion at Week 12

Description

The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.

Time Frame

Baseline, Week 12 (LOCF)

Title

Change From Baseline in Swollen Joint Index at Week 12

Description

44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.

Time Frame

Baseline, Week 12 (LOCF)

Title

Change From Baseline in Hs-CRP at Week 12

Description

Time Frame

Baseline, Week 12 (LOCF)

Title

Change From Baseline in ASAS Individual Components at Week 12

Description

Time Frame

Baseline, Week 12 (LOCF)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840006

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number 840033

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Investigational Site Number 840027

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Investigational Site Number 840007

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Investigational Site Number 840013

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Investigational Site Number 840017

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Investigational Site Number 840009

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Investigational Site Number 840001

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Investigational Site Number 840032

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Investigational Site Number 840015

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Investigational Site Number 840021

City

Rock Island

State/Province

Illinois

ZIP/Postal Code

61201

Country

United States

Facility Name

Investigational Site Number 840018

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7321

Country

United States

Facility Name

Investigational Site Number 840003

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Investigational Site Number 840029

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Investigational Site Number 840008

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48823

Country

United States

Facility Name

Investigational Site Number 840002

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Investigational Site Number 840028

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Investigational Site Number 840016

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Investigational Site Number 840036

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Investigational Site Number 840010

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

Investigational Site Number 840005

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Investigational Site Number 840023

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Investigational Site Number 840014

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Investigational Site Number 840004

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 840030

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Investigational Site Number 840034

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Investigational Site Number 036001

City

East Malvern

ZIP/Postal Code

3145

Country

Australia

Facility Name

Investigational Site Number 036003

City

Hobart

ZIP/Postal Code

7001

Country

Australia

Facility Name

Investigational Site Number 036004

City

Shenton Park

ZIP/Postal Code

6008

Country

Australia

Facility Name

Investigational Site Number 036002

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Investigational Site Number 040001

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Investigational Site Number 040002

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

Investigational Site Number 056003

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Investigational Site Number 056005

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Investigational Site Number 056002

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 056004

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Investigational Site Number 124007

City

London

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Investigational Site Number 124004

City

Montreal

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Investigational Site Number 124008

City

Newmarket

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

Investigational Site Number 124003

City

Pointe-Claire

ZIP/Postal Code

H9R 3Z2

Country

Canada

Facility Name

Investigational Site Number 124001

City

Quebec

ZIP/Postal Code

G1V 4R4

Country

Canada

Facility Name

Investigational Site Number 124006

City

Saskatoon

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

Investigational Site Number 124005

City

Toronto

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Investigational Site Number 124009

City

Trois-Rivières

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Investigational Site Number 124002

City

Vancouver

ZIP/Postal Code

V5Z 1L7

Country

Canada

Facility Name

Investigational Site Number 124010

City

Vancouver

ZIP/Postal Code

V5Z 3Y1

Country

Canada

Facility Name

Investigational Site Number 203003

City

Brno

ZIP/Postal Code

63800

Country

Czechia

Facility Name

Investigational Site Number 203005

City

Hlucin

ZIP/Postal Code

74801

Country

Czechia

Facility Name

Investigational Site Number 203002

City

Hradec Kralove

ZIP/Postal Code

50005

Country

Czechia

Facility Name

Investigational Site Number 203001

City

Praha 2

ZIP/Postal Code

12850

Country

Czechia

Facility Name

Investigational Site Number 203004

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Investigational Site Number 250001

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Investigational Site Number 250005

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Investigational Site Number 250002

City

Creteil Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Investigational Site Number 250003

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Investigational Site Number 276002

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Investigational Site Number 276004

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Investigational Site Number 276003

City

Frankfurt Am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Investigational Site Number 276005

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Investigational Site Number 276001

City

Herne

ZIP/Postal Code

44652

Country

Germany

Facility Name

Investigational Site Number 348001

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Investigational Site Number 348003

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 348005

City

Sátoraljaújhely

ZIP/Postal Code

3980

Country

Hungary

Facility Name

Investigational Site Number 348004

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Investigational Site Number 440001

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Investigational Site Number 440002

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Investigational Site Number 528001

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Investigational Site Number 528002

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Investigational Site Number 616002

City

Bialystok

ZIP/Postal Code

15-354

Country

Poland

Facility Name

Investigational Site Number 616001

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Investigational Site Number 616004

City

Lublin

ZIP/Postal Code

20-607

Country

Poland

Facility Name

Investigational Site Number 616005

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Investigational Site Number 616003

City

Warszawa

ZIP/Postal Code

02-637

Country

Poland

Facility Name

Investigational Site Number 724005

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Investigational Site Number 724004

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724002

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Investigational Site Number 724001

City

Sevilla

ZIP/Postal Code

41008

Country

Spain

Facility Name

Investigational Site Number 792002

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792001

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

24550171

Citation

Sieper J, Braun J, Kay J, Badalamenti S, Radin AR, Jiao L, Fiore S, Momtahen T, Yancopoulos GD, Stahl N, Inman RD. Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN). Ann Rheum Dis. 2015 Jun;74(6):1051-7. doi: 10.1136/annrheumdis-2013-204963. Epub 2014 Feb 18.

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

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

Ankylosing Spondylitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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