Investigation of the molecular size distribution of hyaluronan and the effect of adalimumab treatment of psoriatic arthritis.

Active, not recruiting

Conditions: Active psoriatic arthritis according to CASPAR
MedDRA version: 14.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2012-004940-31-SE

Lead Sponsor: Dept of medical sciences, Rheumatology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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)
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

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
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The proportion of low molecular mass of hyaluronan in skin biopsies from psoriatic arthritis patients compared to healthy subjects.;Timepoint(s) of evaluation of this end point: Baseline, 2 weeks, 6 weeks and 3 months.;Main Objective: To study the molecular mass of HA in skin and circulation and relate the molecular weight distribution of HA to the clinical and histological inflammatory picture in psoriatic arthritis (PsA) patients with active disease. <br>;Secondary Objective: To study the effect of anti-TNF-alpha treatment (adalimumab) after three months with regard to HA molecular weight distribution in psoriatic arthritis (PsA) patients with active disease.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - The proportion of LMM HA in suction blisters from psoriatic arthritis patients compared to healthy subjects.<br><br>- Reversability of LMM HA in skin biopsies from psoriatic arthritis patients by adalimumab at three months compared to baseline.<br><br>- Reversability of LMM HA in suction blister fluids from psoriatic arthritis patients by adalimumab at three months compared to baseline.<br><br>- Potential correlations between LMM HA and disease activity measured as Composite Psoriatic Disease Activity Index (CPDAI) at baseline and at 3 months.<br> <br>- Potential correlation with radiographic score (according to Wassenberg) and LMM HA at baseline only. Radiography will only be performed once as 3 months is a too short period to expect progression.<br>;Timepoint(s) of evaluation of this end point: Baseline and 3 months.