A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
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|ClinicalTrials.gov Identifier: NCT00963313|
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : September 23, 2014
|Condition or disease||Intervention/treatment|
|Psoriatic Arthritis||Drug: Adalimumab (HUMIRA®)|
A recent review from GRAPPA group evaluates therapies for PsA including peripheral and axPsA. Analysing particularly the results with present biologic therapies it has been proven that outcome data at 24 weeks show excellent results in the treatment of peripheral forms of PsA with either of the three biologics disposable in the market, that is to say infliximab, etanercept and adalimumab.
However when it comes to analyse data on PsA patients with axPsA there are not results at all. The design of clinical trials did not evaluate axial outcomes and therefore there is not a possibility of knowing whether these therapies are useful in axPsA.
This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40 mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving Methotrexate, Sulfasalazine, Leflunomide or Cyclosporine, plus NSAIDs and no more than 10 mg of corticosteroids.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2014|
Adalimumab, one injection every fourteen days during 24 weeks.
Drug: Adalimumab (HUMIRA®)
Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks.
Other Name: HUMIRA®
- BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index). [ Time Frame: 12 WEEKS ]Proportion of patients that reach a BASDAI 50% at week 12, BASDAI 50% means an improvement from baseline of 50% or an improvement of two units on a 10 unit scale.
- Number of participants with new adverse events. [ Time Frame: 24 WEEKS ]
- ASAS 40 score. [ Time Frame: 24 WEEKS ]
- ASAS 50 and ASAS 70 score, 5/6. [ Time Frame: 12 WEEKS ]
- Evaluation of enthesitis. [ Time Frame: 24 WEEKS ]
- Peripheral articulation measured with DAS 28. [ Time Frame: 24 WEEKS ]
- Evaluation of extraarticular manifestations. [ Time Frame: 24 WEEKS ]
- Measure of laboratory parameters. [ Time Frame: 24 WEEKS ]Hematology, biochemistry, CRP, ESR, HLA-B27 and rheumatoid factor.
- Evaluation of quality of life. [ Time Frame: 24 WEEKS ]SF36
- Measure of PASI (Psoriasis Area and Severity Index). [ Time Frame: 24 WEEKS ]
- Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index). [ Time Frame: 24 WEEKS ]
- Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index). [ Time Frame: 24 WEEKS ]
- Evaluation of health. [ Time Frame: 24 WEEKS ]HAQ (Health Assessment Questionarie).
- Evaluation of dactylitis. [ Time Frame: 24 WEEKS ]
- Measure of inflammatory biomarkers (IL6 and MMP3). [ Time Frame: 24 WEEKS ]
Biospecimen Retention: Samples Without DNA
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): NCT00963313
|Study Chair:||Francisco J. Blanco-Garcia, MD, PhD||Complejo Hospitalario Universitario A Coruna|