E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active psoriatic arthritis according to CASPAR |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic arthritis is a painful joint condition connected to psoriasis. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of low molecular mass of hyaluronan in skin biopsies from psoriatic arthritis patients compared to healthy subjects. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 2 weeks, 6 weeks and 3 months. |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
10 healthy volunteers will be used for comparison. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |