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Clinical Trials/EUCTR2012-004940-31-SE
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.

Registry
who.int
Start Date
April 3, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dept of medical sciences, Rheumatology

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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