Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement.
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
Enrollment
29
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.
Complejo Hospitalario Universitario A Coruna
A Coruña, A Coruna, Spain
BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index).
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.
Time frame: 12 WEEKS
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.
Hematology, biochemistry, CRP, ESR, HLA-B27 and rheumatoid factor.
Time frame: 24 WEEKS
Evaluation of quality of life.
SF36
Time frame: 24 WEEKS
Measure of PASI (Psoriasis Area and Severity Index).
Time frame: 24 WEEKS
Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Arquitecto Marcide-Novoa Santos
Ferrol, A Coruna, Spain
Hospital de Elche
Elche, Alicante, Spain
Hospital Comarcal Villajoyosa
Villajoyosa, Alicante, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Vall d´Hebron
Barcelona, Barcelona, Spain
Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Hospital Basurto
Bilbao, Bilbao, Spain
Hospital San Pedro de Alcantara
Cáceres, Caceres, Spain
...and 12 more locations
Time frame: 24 WEEKS
Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index).
Time frame: 24 WEEKS
Evaluation of health.
HAQ (Health Assessment Questionarie).
Time frame: 24 WEEKS
Evaluation of dactylitis.
Time frame: 24 WEEKS
Measure of inflammatory biomarkers (IL6 and MMP3).
Time frame: 24 WEEKS