JAKPOT (JAK Inhibitors and Predictors of Outcome in RheumaToid Arthritis)

NCT04084223 | Terminated

• 1 other identifier: RECHMPL18_0241
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Sustained remission or low disease activity is the target to achieve in RA management. Ultrasound (US) is an imaging technique potentially helpful at several steps of the disease. A semi-quantitative (0-3) score of synovitis combining B-mode and Power Doppler abnormalities has been developed (GLOESS), and its responsiveness has been demonstrated. Patients Reported Outcomes (PROs) are important parameters in patient perceived health and are increasingly used in clinical practice. Prediction of therapeutic response to biological and targeted synthetic DMARDs remains a challenge for clinician, due to the potential adverse events and the cost of these drugs. To date, only few clinical and biological tools usable in clinical practice have a prognostic value. US or PRO could have added value for this purpose. Objectives :

• To determine the predictive added value of the variation of an US score to the variation of the DAS28-CRP (C-Reactive Protein) at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP≤3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAK (Janus Kinase) inhibitors (JAKi).
• To determine the predictive added value of the variation several PROs to the variation of the DAS28-CRP at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP≤3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAKi.

Conditions

Rheumatoid Arthritis

Keywords

JAK Inhibitors; Ultrasound; Patients Reported Outcomes (PROs); Disease activity; Predictors; Therapeutic response

Outcome Measures

Primary Outcomes (1)

• Disease activity

  DAS28-CRP evaluated by an ultra-sound-blinded investigator (score calculated with number of painful articulations, synovitis, and C-Reactive Protein ; DAS28 result \> 3,2 : moderately active rheumatoid arthritis)

  6 months

Secondary Outcomes (9)

• Disease activity

  1 month

• Disease activity

  3 months

• Ultra-sound activity

  1 month

• Ultra-sound activity

  3 months

• Ultra-sound activity

  6 months

Study Arms (1)

Active RA patients group

EXPERIMENTAL

64 active RA patients (DAS28\>3,2 AND presence of ≥2 US synovitis with Power-Doppler≥2) with an inadequate response to methotrexate (MTX) starting a treatment with JAKi (tofacitinib ou baricitinib) will be evaluated at baseline, 1, 3 and 6 months in 5 centres. A clinical joint assessment will be performed and CRP will be tested to calculate DAS28-CRP. Several PROs will be completed: RAPID3, HAQ, pain, and patient global assessment of disease activity on a VAS. An US exam on 40 joints and 12 tendons will be performed by an independent investigator, looking for synovitis and tenosynovitis with B-Mode and Power Doppler. A Global US score (GLOESS) will be collected at each visit.

Other: Ultrasound

Interventions

Ultrasound OTHER

An Ultrasound exam (not performed in routine care) will be performed at Baseline, 1, 3 and 6 months for protocol. All patients will also have CRP dosage (for DAS28 assessment), RAPID-3 and PROs (performed in routine care but analyzed for the study).

Active RA patients group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥18 years
• (American College of Rheumatology) ACR-EULAR classification criteria for RA for ≥3 months
• Inadequate response to MTX (or other csDMARD) for ≥3 months, at stable dosage for ≥1 month
• Active disease defined by DAS28\>3,2 AND presence of ≥2 US synovitis with Power-Doppler≥2,
• Starting a treatment with JAKi (baricitinib or tofacitinib),
• Patients previously treated with biologic (stopped for inadequate response or safety) could be included. Biologics will be stopped before entering in the study: Abatacept and all TNF (tumor necrosis factor) inhibitors: no use within 4 weeks before baseline visit; Rituximab: no use within 6 months before baseline visit.
• Informed signed consent

You may not qualify if:

• Patient not treated before by MTX (or other csDMARD). Patients with a contraindication or in whom MTX was stopped due to safety issue could be included. Patients treated by MTX will have MTX during the follow-up, others will be treated by JAKi monotherapy,
• Patients with a contraindication to baricitinib or tofacitinib (current infection, recent attenuated vaccine injection, cancer \<5 years…) or treated previously with baricitinib or tofacitinib,
• Patients treated by glucocorticoids ≥10 mg/day and unstable dosage for \<1 month or with ≥1 glucocorticoids injection \<1 month.
• RA with Steinbrocker class IV damage status
• Refusal to participate in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• University Hospital, Bordeaux: collaborator
• University Hospital, Toulouse: collaborator

Study Sites (1)

Rheumatology Department, Lapeyronie Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Gaël MOUTERDE, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: September 10, 2019
• Study Start: October 10, 2019
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)