Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

3 Mar 2020 → 9 Dec 2025

Decision date (initial)

2024-04-03

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

The Aspire program courtesy of Pfizer: independent research grant

External identifiers

EU CT number

2024-511401-40-00

EudraCT number

2019-004177-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the effect of tofacitinib in remission induction and to document extended drug-free follow-up status after treatment with tofacitinib in early DMARD naïve PsA patients.

Secondary objectives 1

1. To explore the underlying molecular mechanisms in affected synovium with the aim of treatment response prediction.

Conditions and MedDRA coding

Psoriatic Arthritis

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. - Age ≥ 18 years
2. - Clinical diagnosis of PsA made by rheumatologist and fulfilling criteria defined by the classification Criteria for PsA (CASPAR)
3. - Onset of PsA symptoms ≤ 24 weeks prior to screening visit
4. - Active disease per rheumatologist’ss opinion
5. - At least 1 swollen joint which is suitable for ultrasound guided synovial biopsy at BL
6. - Women of childbearing age and men capable of fathering children have to use adequate birth control measures during the study and for 6 months after the last administration of the study medication
7. - Able and willing to give written informed consent and participate in the study

Exclusion criteria 12

1. -Previous treatment with: DMARDs; Oral, IA, IV or IM GC’s within 4 weeks before BL; IA steroids in the target joint ≤ 6 weeks before synovial biopsy; An investigational drug for the treatment/prevention of PsA
2. - History of any inflammatory rheumatic disease other than PsA
3. - Use of anticoagulation or anti-aggregation therapy (other than low-dose aspirin and NSAIDs)
4. - Intolerance/allergy to lidocaine
5. - Underlying hematological, thromboembolic, cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
6. - Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
7. - Active hepatitis B and C infection
8. - Active tuberculosis (TB)
9. - Latent TB unless adequate prophylactic treatment is given according to local guidelines
10. - Alcohol or drug abuse
11. - History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex
12. - History of malignancies within the last 5 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - The proportion of patients achieving a status of clinical remission at week 24.

Secondary endpoints 6

1. - The proportion of patients in drug-free remission at week 52 and week 104.
2. - Time to relapse in patients experiencing a flare after treatment cessation.
3. - The evolution of arthritis, dactylitis, enthesitis and skin involvement at week 4, week 12, week 24, week 28, week 52, week 76 and week 104, measured by : SJC66/TJC68; Dactylitis severity score; Leeds enthesitis index; BSA
4. - The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: PGA; Health Assessment Questionnaire – disability index (HAQ); Short Form-36 physical functioning domain(SF-36); EuroQol 5- dimension Health state Profile (EQ-5D); PsA Impact of Disease (PsAID)
5. - Percentage of patients achieving the PsA response criteria (PsARC), minimal disease activity (MDA) and 85% change in Disease activity (DAPSA) at week 12, week 24, week 52, week 76 and week 104
6. - Radiographic progression at week 52 and week 104

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Barbara Neerinckx

Public contact point

Organisation

UZ Leuven

Contact name

Barbara Neerinckx

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications