Spondylitis Trial of Apremilast for Better Rheumatic Therapy (START)
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.
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. 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.
|Ankylosing Spondylitis||Drug: Apremilast Drug: Placebo (sugar pill)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- To demonstrate the effect of apremilast on MRI lesions in AS [ Time Frame: 3 months ]
- To explore the effect of apremilast on the signs and symptoms of AS [ Time Frame: 4 months ]
- To explore the safety and tolerability of apremilast in AS [ Time Frame: Day 1 - day 113 ]
|Study Start Date:||August 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Apremilast||
As per protocol
Other Name: As per protocol
|Placebo Comparator: Sugar pill||
Drug: Placebo (sugar pill)
As per protocol
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944658
|The Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Peter Taylor||Imperial College London|