Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL)
- Conditions
- ankylosing spondylitis (AS)MedDRA version: 21.1Level: LLTClassification code 10041672Term: Spondylitis ankylosingSystem Organ Class: 100000004859MedDRA version: 21.1Level: LLTClassification code 10048398Term: Spondylitis ankylosing aggravatedSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-000615-33-DE
- Lead Sponsor
- Charite Universitaetsmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
1.Age =18 years.
2.Definite diagnosis of AS according to the modified New York criteria1.
3.History of an inadequate response to =2 NSAIDs taken for at least 2 weeks each.
4.Active disease as defined by a BASDAI value of =4 at screening and baseline.
5.Presence of at least one of the following risk factors for radiographic spinal progression:
•Elevated CRP (>5mg/l) at screening at the absence of reasons for elevated CRP other than AS;
•Presence of = 1 syndesmophyte on prior X-rays of the spine.
6.Subject is a candidate for anti-TNF therapy based on the investigator’s opinion.
7.Subject is able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be included in the trial.
8.If female: either unable to bear children or is willing and able to practice a reliable method of contraception throughout the study and 6 months after the last dose of study drug
9.If on NSAIDs: the dose must be stable for at least 2 weeks prior to baseline.
10.If on oral steroids: the dose must not exceed 10 mg (prednisolone equivalent) per day and must be stable for at least 2 weeks prior to baseline.
11.If on methotrexate: the dose must not exceed 25 mg per week and must be stable for at least 4 weeks prior to baseline.
12.If on sulfasalazine: the dose must not exceed 3 g per day and must be stable for at least 4 weeks prior to baseline.
13.If on analgesics: the dose must be stable for at least 2 weeks prior to baseline.
Phase II of the study:
1.Achievement of at least 50% improvement or >=2 absolute points (on a 0-10 scale) reduction of the BASDAI after 12 weeks of Golimumab treatment in the Phase I.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- for female subjects: pregnancy or lactating.
- subjects with chronic inflammatory articular disease other than SpA or systemic autoimmune disease.
- history of inadequate response (primary non-response) to previous anti-TNF therapy.
- treatment with any other investigational drug within 3 months of 5 half-lifes of the drug (whichever is longer) prior to Baseline visit.
- history of intolerability or hypersensitivity reaction study drugs
- any active current infection. History of recurrent clinically significant infection (suggestive for primary or secondary immunodeficiency). Infections requiring treatment with antibiotics within 4 weeks prior to baseline.
- current clinical signs and symptoms suggestive for tuberculosis.
- positive QuantiFERON®-TB Gold In-Tube 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 Gold In-Tube test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic anti-tuberculous treatment.
- chronic infection with hepatitis B or C, history of HIV infection.
- malignancies
- demyelinating disease (like multiple sclerosis; including myelitis)
- history of cardiovascular events or high cardiovascular risk
- history of GI ulceration or any clinically relevant GI bleeding, perforation, or gastric outlet obstruction.
- History of a chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
- evidence of other severe uncontrolled disorders.
- diagnosis of fibromyalgia.
- several abnormalities of laboratory values as defined in the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method