Ankylosing Spondylitis Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS)
This study will evaluate the effectiveness of apremilast in AS as measured by improvement in patients' signs and symptoms of the disease and changes in imaging. Additionally the safety and tolerability of apremilast in AS will be assessed.
Presently, there are very few treatments available which affect the progression of the
disease in the spine. The only proven treatment is the use of drugs inhibiting tumour
necrosis factor alpha (TNF). However, there are limitations with this treatment in that it
needs to be administered via an injection and is also very expensive. Therefore it is
necessary to develop new therapeutic agents for this condition.
Apremilast (the study drug) is an oral tablet which has been shown to inhibit TNF production
in a mouse model of inflammation. It has also been used in clinical trials for asthma and
psoriasis in humans with good affect and tolerability.
These studies were funded by Celgene Corporation and they will be funding this study.
The patients will be recruited from hospitals by Consultant referral. The patients will have
had AS for at least 2 years and their symptoms will have been uncontrolled on conventional
non−steroidal anti−inflammatory drugs such as ibuprofen. Patients will be randomised to
either receive apremilast or a placebo and treated over a period of 12 weeks. They will then
be followed up for 28 days after the treatment period.
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