EUCTR2012-004940-31-SE
Active, not recruiting
Not Applicable
Dermal inflammation in psoriatic arthritis, the association to molecular mass of hyaluronan and effect of adalimumab.A prospective, open-label, multi-center study of hyaluronan molecular mass distribution in psoriatic arthritis patients compared to healthy subjects.
Dept of medical sciences, Rheumatology0 sitesApril 3, 2013
DrugsHumira
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dept of medical sciences, Rheumatology
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(applies to patients only):
- •1\. Age 18 years or older
- •2\. Fulfil the classification criteria for psoriatic arthritis according to CASPAR
- •3\. RF (reumatoid factor) and ACPA (anticitrullinated protein/peptide antibody) negative
- •4\. Have a psoriatic plaque lesion with inflammation that can be biopsied/adapt suction blister on
- •5\. Have no other inflammatory joint or skin disease
- •6\. No previous treatment with anti\-TNF\-alpha
- •7\. Active psoriatic arthritis defined as fulfilling the criteria for treatment with anti\-TNF in PsA according to Swedish Guidelines in Swedish Association for rheumatology;
- •a/High activity with polyarthritis or dachtylitis and increased SR or CRP.
- •b/Treatment failure on NSAID/local steroids and one DMARD (methotrexate, sulphasalazine, leflunomide, gold salts, cyclosporine)
Exclusion Criteria
- •(applies to patients only) :
- •1\. Active or latent tuberculosis
- •2\. Chronic infections including hepatitis B and C
- •3\. Chronic liver diseases
- •4\. Malignancy
- •5\. Congestive heart failure
- •6\. Severe infections such as sepsis
- •7\. Opportunistic infections
- •8\. Positive pregnancy test at inclusion or at deviation of menstruation during study, and/or lactating woman of reproductive age
- •9\. Not able to use adequate contraception during treatment and five month after treatment with adalimumab in woman of reproductive age
Outcomes
Primary Outcomes
Not specified
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