sTekinumab for the treatment Of Patients with active Ankylosing Spondylitis
- Conditions
- Ankylosing spondylitisMedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-000844-56-DE
- Lead Sponsor
- Charité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Age of =18 years.
2.Definite diagnosis of AS according to the modified New York criteria.
3.History of an inadequate response to =2 NSAIDs taken for at least 2 weeks each or NSAIDs intolerance/contraindication.
4.Active disease as defined by a BASDAI value of =4 at screening despite concomitant treatment with an NSAID or without NSAIDs in case of intolerance/contraindication.
5.Able and willing to give a written informed consent and comply with the requirements of the study protocol.
6.If female: either not of child-bearing potential (menopausal since 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study and 150 days after the last drug injection. Reliable methods of contraception are: condoms and other barrier methods, intrauterine devices, oral, parenteral or intravaginal contraceptives initiated at least 90 prior to screening, a vasectomised partner.
7.If male: either not of child-bearing potential (surgically sterilized, e.g. vasectomy) or is willing and able to practice a reliable method of contraception throughout the study and 150 days after the last drug injection.
8.If on NSAIDs: the dose must be stable for at least 2 weeks prior to baseline.
9.If on oral steroids: the dose must not exceed 10 mg (prednisolone equivalent) per day and must be stable for at least 4 weeks prior to baseline.
10.If on methotrexate: the dose must not exceed 25 mg per week and must be stable for at least 4 weeks prior to baseline, must be stable for 4 weeks prior to baseline.
11.If on analgesics: the dose must be stable for at least 2 weeks prior to baseline.
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.The female subject is pregnant or lactating.
2.Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. systemic lupus erythematosus, Sjögren syndrome, rheumatoid arthritis, chronic fatigue syndrome (other manifestations of spondyloarthritis such as psoriasis, inflammatory bowel disease, arthritis, uveitis are not regarded as exclusion criteria).
3.History of inadequate response to previous anti-TNF a therapy. Patients who discontinued previous anti-TNF a therapy due to intolerability/side effects may participate in the study. This therapy must have been terminated at least 4 weeks prior to baseline if etanercept was used and at least 8 weeks if infliximab, adalimumab, or golimumab were used.
4.Previous treatment with biologics other than TNF a blockers.
5.Treatment with any other investigational drug within 4 weeks of 5 half-life of the drug (whichever is longer) prior to baseline.
6.Treatments with disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate within 4 weeks prior to screening (8 weeks for leflunomide or 4 weeks with a standard cholestyramine wash-out).
7.Treatment with intravenous, intramuscular or intraarticular/periarticular steroids within 4 weeks prior to screening.
8.Any active current infection, a history of recurrent clinically significant infection, infections requiring treatment with antibiotics within 4 weeks prior to baseline.
9.Current clinical signs and symptoms suggestive for tuberculosis.
10.Positive QuantiFERON®-TB test at screening and/or abnormal chest x-ray (performed at screening or within 3 months prior to screening) suggestive for past or present tuberculosis (positive x-ray). Patients with a positive QuantiFERON®-TB test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic antimycobacterial treatment.
11.Chronic infection with hepatitis B or C, history of HIV infection.
12.Primary or secondary immunodeficiency.
13.Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous-cell or basal-cell carcinoma or carcinoma in situ of the cervix.
14.Evidence of severe uncontrolled gastrointestinal, hepatic, renal, pulmonary, cardiovascular, nervous or endocrine disorders.
15.Any other conditions making the patient unsuitable in the opinion of the investigator for the participation in the current study.
16.Patients with a history of a severe psychiatric illness, which might interfere with the patient's ability to understand the requirements of the study and assessment.
17.Diagnosis of fibromyalgia.
18.Alcohol abuse or illegal drug consume in the last 12 months.
19.Vaccination with a live vaccine within 12 weeks prior to baseline.
20.Known hypersensitivity to any component of the study medication.
21.Any of the following laboratory abnormalities as detected at screening:
o Haemoglobin < 8.5 g/dl
o Neutrophil counts < 2.000 / µl
o Platelet count < 125.000 / µl
o Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men.
o Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (AP) or gamma-glutamyl-transpeptidase (GGT) >3 times upper limit of normal
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of efficacy and safety of ustekinumab 90 mg administered subcutaneosly at week 0, week 4 and week 16 in patients with active AS (the Bath Ancylosing Spondylitis Disease Activity Index – BASDAI =4) fulfilling the modified New York criteria who have had an inadequate response to =2 NSAIDs or do not tolerate or have a contraindication for NSAIDs.;Secondary Objective: • Course of change of active and chronic inflammatory lesions in MRI over 24 weeks <br>• Change in the cytokine production by T-cells and monocytes over 24 weeks<br><br><br>;Primary end point(s): The Assessment of Spondyloarthritis International Society (ASAS)40 response at week 24 defined as an improvement of =40% and =2 points in at least 3 out of 4 following domains (and no worsening in remaining domain) :<br>- Patient global<br>- Pain<br>- Function (BASFI)<br>- Inflammation (mean of the BASDAI question 5 and 6).<br>;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method