TIGERS study proposes to take mini fragments of synovial tissue to study the molecular patterns present in psoriatic arthritis, in order toto identify markers of disease progression and response to treatment with Ustekinumab, Guselkumab or Adalimumab to analyze and compare different expression patterns within synovial and cutaneous tissue , and to investigate whether molecular diagnosis allows to predict the evolution of the disease in the long term, as well as the therapeutic response.

Phase 1

• Conditions: Psoriatic arthritis (PsA); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-003249-18-BE
• Lead Sponsor: Cliniques Universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-02
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
2.Male or non-pregnant, non-nursing female patients at least 18 years of age.
3.Patients with active PsA according to CASPAR criteria for =6 months, despite =3 months of csDMARD therapy, and =4 weeks of non-steroidal anti- inflammatory drugs (NSAIDs) therapy.
4.At least 1 swollen joint at screening or baseline (despite csDMARD therapy) with ability to perform a synovial biopsy at W0.
5.Patients with newly documented latent TB are eligible provided initiation of appropriate treatment.
6.Concomitant MTX or SSZ is permitted if started =3 months prior to study start and at a stable dose (=25 mg/week for MTX and = 3 g/day for SSZ) for =4 weeks.
7.Patients on MTX must be on stable folic acid supplementation before randomization.
8.Concomitant NSAIDs and oral corticosteroids (=10 mg prednisone/day) are permitted if stable for at least 2 weeks.
9.Allowed concomitant medications are to remain stable through week 24.
10.Patients cannot have previously received any biologic agent.
11.DMARDs other than MTX or sulfasalazine (SSZ) must be interrupted. DMARDs other than MTX are not allowed within 4 weeks prior to or during trial participation. A washout period needs to be considered. (8 weeks for leflunomide).
12.At least one joint (small or large) to biopsy in order to get synovial tissue. Small joints must have an US grey-scale score > 2 on Doppler

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 6

Exclusion Criteria

1.Contraindications for needle-arthroscopy such as joint replacement (in the affected knee or ankle joint) or anticoagulation.
2.Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer.
3.Conditions/situations such as:
a.Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint

b.Impossibility to meet specific protocol requirements (e.g. blood sampling)
c.Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
d.Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures

4.Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline.
5.Any intramuscular corticosteroid injection within 2 weeks before baseline.
6.Prior treatment with a biologic agent.
7.A history of active tuberculosis (TB).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified