Spondylitis Trial of Apremilast for Better Rheumatic Therapy (START)
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|ClinicalTrials.gov Identifier: NCT00944658|
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : December 6, 2019
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Drug: Apremilast Drug: Placebo (sugar pill)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Placebo Comparator: Placebo
placebo twice a day for 12 weeks, 4 weeks follow up
Drug: Placebo (sugar pill)
twice a day
Active Comparator: Apremilast
30 mg twice a day for 12 weeks, 4 weeks follow up
10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
- Changes of Apremilast in Patients With AS, Changes in BASDAI Score From Baseline [ Time Frame: Baseline and 12 weeks ]Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.
- Changes of Apremilast on the Signs and Symptoms of AS, Night Pain From Baseline [ Time Frame: Baseline and 12 weeks ]
This endpoint the night time pain score change was recorded by questionnaire to evaluate the Apremilast effect on symptom, higher reduction better improvement.
scale is 0-10
- Effect of Apremilast in Patients With AS, Changes in BASFI Score [ Time Frame: Baseline and 12 weeks ]Bath Ankylosing Spondylitis Functional Index (BASFI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.
- The Safety and Tolerability of Apremilast in AS, Number of Participants With Adverse Events [ Time Frame: 16 weeks ]To evaluate the safety and tolerability of Apremilast in AS, the investigator recorded the incidence of adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944658
|The Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Peter Taylor||Imperial College London|