E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
psoriatic arthritis |
artritis psoriatica |
|
E.1.1.1 | Medical condition in easily understood language |
psoriatic arthritis |
artritis psoriatica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066579 |
E.1.2 | Term | Progression of psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066730 |
E.1.2 | Term | Recurrent psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003377 |
E.1.2 | Term | Arthropathy psoriatic |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037161 |
E.1.2 | Term | Psoriatic arthritis aggravated |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037162 |
E.1.2 | Term | Psoriatic arthropathy |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10037163 |
E.1.2 | Term | Psoriatic arthropathies |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037166 |
E.1.2 | Term | Psoriatic spondylitis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 |
The overall aim of the study is to determine which downstream cellular and molecular pathways involved in PsA pathogenesis are modulated by IL23/12 P40 blockade. As we have ample evidence that relevant disease-specific pathways are found in the primary target tissues, in particular in synovial tissue obtained from peripheral joints, but not in peripheral blood, we will strongly focus on this compartment by obtaining paired biopsies before and after treatment
The primary objective is to assess the effect of IL23/12 P40 blockade on:
- the global synovial histology and inflammatory infiltration
- the number and type of IL-17 producing cells in PsA synovitis
- the production of inflammatory mediators (including IL-17 related cytokines such as IL-22, and pther pro-inflammatory cytokines such as TNF) by total synovial tissue biopsies (ex vivo culture system) as well as by peripheral blood cells
- the synovial stromal cell signature
- the pan-genomic synovial gene expression profile |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare which molecular disease pathways are affected by IL23/12 P40 blockade and not by TNF blockade and thereby identify molecular biomarkers which may help to determine which patients may benefit from this treatment in comparison with anti-TNF treatment.
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|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Psoriatic arthritis according to CASPAR criteria
- Active disease defined as: Swollen Joint count ≥3 and Tender Joint count ≥3
- Presence of knee and/or ankle arthritis in order to get synovial tissue biopsies
|
|
E.4 | Principal exclusion criteria |
- Previous use of il-17 blocking therapy or multiple use of tnf-blocking therapies
- Contra-indication for needle arthroscopy such as joint replacement and anti-coagulation use.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in the synovial cellular and molecular pathways as indicated in the objectives between baseline and week 12 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline in comparison with week 12 |
|
E.5.2 | Secondary end point(s) |
- stratification of these cellular and molecular changes according to the genetic biomarkers of relevance for anti-IL12/23 treatment
- comparison of the synovial/molecular changes induced by anti-Il12/23 treatment response with the changes induced by anti-TNF treatment (i.c.w. samples from a previous performed trial at this center)
-correlation between the synovial features at baseline and week 12
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|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |