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NCT Number: NCT04602091

Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)

Janus kinase (JAK) inhibitors are a new class of molecules available to the therapeutic arsenal for chronic inflammatory rheumatic diseases.The tolerance profile of this new class needs to be better defined and its use in real life further established.

The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.

This registry will include at least 1500 Rheumatoid Arthritis (RA) and 150 patients with psoriatic arthritis from the start of treatment with JAK inhibitor and then followed for 5 years.

This registry is a longitudinal, multicentre, observational registry study. The objective of this national registry is to get a better understanding of the safety profiles of JAK inhibitors and get knowledge of their use in daily practice in order to optimize this use and potentially integrate JAK inhibitors into personalised medicine strategies.

This registry will generate efficacy data, especially therapeutic maintenance, observation, allowing inter-registry comparisons with other biologic compounds in the French population, and can be aggregated with other similar registries in other countries.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Connective Tissue Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Inflammatory Rheumatism Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatic Fever Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondyloarthritis Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Antibes, Antibes, France

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About this study

Design:

This registry is a longitudinal, multicentre, observational registry study, with continuous and ambispective collection of clinical and laboratory data. The patients will be followed for 5 years, regardless of the therapeutic modifications occurring thereafter.

Target population:

Patients initiating JAK inhibitor therapy for inflammatory rheumatic disorder.

Number of patients and centres :

  • The objective is to include, per drug available on the market, at least 300 to 500 patients with RA and at least 100 to 150 patients with psoriatic arthritis. If a JAK inhibitor is approved in a new indication of chronic rheumatic disease by European Medicines Agency (EMA), the number of patients to include for each molecule in this indication will be adjusted as a function of the prevalence/epidemiology of each disease. Products currently available (baricitinib and tofacitinib) will be considered at the start of this registry; then every new indication for an already approved drug or every new drug in the same therapeutic class starting from the date they are placed on the market will be considered.
  • More than 80 centers in France (hospital-based, public and private practice) will participate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18
  • Patient treated with a JAK inhibitor in accordance with EMA, for chronic inflammatory rheumatisms, independent of the therapeutic line
  • Subject who is a member of a social security regime
  • Free, declared, written consent signed by the subject and the investigator on the day of inclusion Exclusion criteria
  • Patient who cannot understand the implications and rules of the study
  • Patient opposition to participating in the study

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Therapeutic maintenance of JAK inhibitors

    Time frame: From the beginning of the study up to Year 1

    The therapeutic maintenance will be measured by the retention rate ie the percentage of patients remaining treated by JAK inhibitors.

Secondary outcomes

  1. Real-life tolerance of JAK inhibitors

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Occurence of adverse events and action taken (temporary or final stop to JAK inhibitor treatment upon the occurrence of adverse event).

  2. Real-life tolerance of JAK inhibitors in sub-groups

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Occurence of adverse events and action taken (temporary or final stop to JAK inhibitor treatment upon the occurrence of adverse event), in an older population or presenting with comorbidities

  3. Efficacy of JAK inhibitors

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Evaluated using clinical data (list is not exhaustive): number of swelling joints (NAG), number of tender joints (NAD), erythrocyte sedimentation rate (ESR), levels of C-reactive protein (CRP), the visual analogic scale (VAS) for disease activity evaluated by the patient and by the physician.

  4. Comparison of JAK inhibitors efficacy (monotherapy versus combination with DMARDS)

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Evaluate the efficacy of JAK inhibitors administered as monotherapy versus combination with a conventional synthetic DMARDs

  5. Efficacy of JAK inhibitors dose (full doses versus half doses)

    Time frame: From the beginning of the study until the end of the 5 years follow-up

  6. Use of JAK inhibitors in current practice

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Starting dosage, therapeutic adjustments, etc.

  7. Place of JAK inhibitors in real-life practice in the treatment arsenal for patients with chronic inflammatory rheumatic disorders

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Therapeutic history of the patient regarding DMARDs before starting treatment with a JAK inhibitor

  8. Patient reported outcomes: Quality of life

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Analyse the effect of JAK inhibitors on patient reported outcomes in regard to quality of life and functional impact : Health Assessment Questionnaire (HAQ) questionnaire

  9. Patient reported outcomes: Acceptance

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Analyse the effect of JAK inhibitors on patient reported outcomes in regard to acceptance : treatment acceptance questionnaire

  10. Patient reported outcomes: Compliance

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Analyse the effect of JAK inhibitors on patient reported outcomes in regard to Compliance : compliance questionnaire (Morisky-Green self-questionnaire)

  11. Drug interactions

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Identify new drug interactions

  12. Analysis if data from a National Health Database (SNIIRAM): demographics

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    With and without chaining to the patients included in this cohort with the possibility of evaluating demographics

  13. Analysis if data from a National Health Database (SNIIRAM): medical economics

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    With and without chaining to the patients included in this cohort with the possibility of evaluating medical economics

  14. Analysis if data from a National Health Database (SNIIRAM): compliance

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    With and without chaining to the patients included in this cohort with the possibility of evaluating compliance

  15. Establishment of an open database

    Time frame: From the beginning of the study until the end of the 5 years follow-up

    Establish an open database which can be integrated with other national registries with a view toward future international analyses

Sponsors and collaborators

Lead sponsor

Societe Francaise de Rhumatologie

Other

Collaborators

  • Bordeaux PharmacoEpi

Registry information

Official study title

JAKINIB Study: " 'Observational', Multicentre Trial Collecting Prospective and On-going Clinical and Laboratory Data for Patients Treated With JAK Inhibitors for Inflammatory Rheumatism According to EMA."

Acronym: MAJIK

Important dates

Study start
2019
Primary completion
2027
Study completion
2030
First posted
Oct 26, 2020
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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