Active psoriatic arthritis according to CASPAR MedDRA version: 14.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Humira
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
Dept of medical sciences, Rheumatology
Eligibility
Sex/Gender
All
Inclusion 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) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of LMM HA in suction blisters from psoriatic arthritis patients compared to healthy subjects. - Reversability of LMM HA in skin biopsies from psoriatic arthritis patients by adalimumab at three months compared to baseline. - Reversability of LMM HA in suction blister fluids from psoriatic arthritis patients by adalimumab at three months compared to baseline. - Potential correlations between LMM HA and disease activity measured as Composite Psoriatic Disease Activity Index (CPDAI) at baseline and at 3 months. - 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. ;Timepoint(s) of evaluation of this end point: Baseline and 3 months. | — |
Countries
Sweden
Contacts
Public ContactDept of medical sciences
University Hospital
Outcome results
None listed