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 个研究点开始时间: 2013年4月3日最近更新: 2013年8月19日

试验速览

暂无简介。

•(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)
•8. Stable dose of DMARD for at least 4 weeks prior to inclusion
•9. Stable dose of NSAIDs and oral corticosteroids for at least 2 weeks prior to inclusion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•(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
•10. Other contraindication to adalimumab in accordance with Swedish SmPC
•11. Diabetes
•12. Metabolic syndrome
•13. Ongoing chondroitin or glucosamine medication
•14. Other reason as evaluated by the investigator

发起方

Dept of medical sciences, Rheumatology