A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

• Register: EUCTR
• Last refreshed on: 18 August 2014
• Main ID: EUCTR2009-016068-35-BE
• Date of registration: 30/11/2009
• Prospective Registration: Yes
• Primary sponsor: Sanofi-aventis Recherche & Développement
• Public title: A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN
• Scientific title: A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN
• Date of first enrolment: 19/02/2010
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016068-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Hungary, Lithuania, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
I 01. Patients with active AS based on the Modified New York criteria for ankylosing
spondylitis.
I 02. Patients must had an adequate trial of at least 2 different NSAIDs taking for at least 2 weeks in each case and on a stable dose for =2 weeks or be intolerant to NSAIDs.
I 03. Active disease must be present for =3 months and be present at screening and at baseline as defined:
- Bath AS Disease Activity Index (BASDAI) score of =4 (NRS 0-10);
- Total back pain score =4 (NRS 0-10).
I 04. Patients treated with corticosteroid must be on a stable dose for >2 weeks prior to baseline.
I 05. Patients treated with DMARDs: hydroxychloroquine, sulfasalazine and MTX must be on a stable dose =12 weeks.
I 06. Patients must give informed consent prior to any procedure related to the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
E 01. Male and female patients age <18 of age or =75 years.
E 02. Weight <50 kg for man or <45 Kg for women or >110 kg for both man or women.
E 03. BASDAI score <4 (NRS 0-10) at screening and baseline.
E 04. Total Back Pain score <4 (NRS 0-10) at screening and baseline.
E 05. Patients with complete fusion of the spine.
E 06. Patient who has previously participated in any clinical trial of SAR153191.
E 07. Participation in any clinical research study evaluating another investigational drug or therapy within 60 days or at least 5 half-lives, whichever is longer, of
investigational drug, prior to Screening Visit.
E 08. Have a history or presence of significant other concomitant illness according to the investigator’s judgment.
E 09. Conditions/situations such as:
- Patients with short life expectancy;
- Patients with conditions/concomitant diseases making them non-evaluable for
primary efficacy endpoint;
- Requirement for concomitant treatment that could bias primary evaluation;
- Impossibility to meet specific protocol requirements;
- Patient is the Investigator or any sub-Investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct of
protocol;
- Uncooperative or any condition that could make patient potentially
non-compliant with study procedures.
E 10. Starting treatment with NSAIDs <4 weeks prior to screening or change current
treatment or dose for =2 weeks prior to baseline.
E 11. Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within
6 weeks prior to screening.
E 12. Use of intramuscular or intra-articular corticosteroids within last 4 weeks before screening.
E 13. Patients who had previously been treated or are currently treated with Disease
Modifying Anti-Rheumatic Drugs or with cyclosporine, azathioprine, or DMARDs
other than methotrexate, sulfasalazine and hydroxychloroquine; and must be on stable dose for =12 weeks; and not to exceed following dose:
- Methotrexate >25 mg/week;
- Hydroxychloroquine >400 mg/day;
- Sulfasalazine >3 gr/day.
E 14. Past history of non response to any anti-TNFs treatment or non response to any other biological treatment for AS.
E 15. Any past or current treatment with anti-TNFs agents or any biological agent within 3 months from screening.
E 16. Pregnant or breast-feeding women.
E 17. For women of childbearing potential, unwillingness to utilize adequate contraception or not become pregnant during full course of study.
E 18. History of alcohol or drug abuse within the 5 years prior to Screening Visit.
E 19. Any subject who has had surgery within 4 weeks prior to Screening Visit or with planned elective surgery.
E 20. History of malignancy other than effectively treated carcinoma in-situ of cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of skin within five years prior to Screening Visit. History of lymphoproliferative disease or possible current lymphoproliferative disease.
E 21. Patients with latent or active tuberculosis.
E 22. Patients with history of Listeriosis or tuberculosis (unless documented that it was adequately treated) (see Section 10.2).
E 23. Fever (=38°C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit, or history of frequent recurrent infections unacceptable per investigator judgment.
E 24. Unhealed infected skin ulcers.
E 25. Received administration

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis
MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis

Intervention(s)

Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective of the study is to evaluate the efficacy by (ASAS20) (Assessment in Ankylosing Spondylitis Working Group responses criteria) of SAR153191 in patients with AS (Ankylosing Spondylitis)

Primary end point(s): The primary efficacy endpoint will be the percentage of patients who achieve the assessment in AS International Working Group Criteria for improvement (ASAS20) at Week 12

Secondary Objective: The secondary objectives are:
assessment of higher level of response ASAS40
partial remission
disease activity
range of motion
changes in MRI score
the safety and tolerability of SAR153191 in patients with AS
to document PK profile of SAR153191 in patients with AS

Secondary ID(s)

DRI11073