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Rheumatoid ArthritisMAJIKNCT04602091

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

An observational study of Rheumatoid Arthritis and Inflammatory Rheumatism, run by Societe Francaise de Rhumatologie at 60 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,300 participants
Where
60 sitesFrance
Study dates
8 Oct 2019to Jun 2030
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: French patients treated for chronic inflammatory rheumatic disorders according to EMA.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

France60 sites

  • CH Antibes

    Antibes

  • Private office

    Bayonne

  • CH Franche Comte

    Belfort

  • CHU de Besançon

    Besançon

  • AP-HP Avicenne

    Bobigny

  • CHU de Bordeaux

    Bordeaux

  • CH Bourg-en-Bresse

    Bourg-en-Bresse

  • CHRU Brest

    Brest

  • CHU Caen

    Caen

  • CH Cannes

    Cannes

  • CH Chartres

    Chartres

  • CH Cholet

    Cholet

  • CHU Clermont Ferrand

    Clermont-Ferrand

  • CH Colombes

    Colombes

  • AP-HP Henri Mondor

    Créteil

  • CH Dax

    Dax

  • CH de Dijon

    Dijon

  • CH de Douai

    Douai

  • CHD de Vendee

    La Roche-sur-Yon

  • CH La Rochelle

    La Rochelle

  • CHG Jacques Monod

    Le Havre

  • AP-HP Bicetre

    Le Kremlin-Bicêtre

  • CH Le Mans

    Le Mans

  • CHU Lille

    Lille

  • Private office

    Limoges

  • CH Saint Philibert

    Lomme

  • CHU Lyon

    Lyon

  • Infirmerie protestante de Lyon

    Lyon

  • CHU Marseille Sainte-Marguerite

    Marseille

  • Hôpital Saint Joseph

    Marseille

  • CH Mont de Marsan

    Mont-de-Marsan

  • CHU de Montpellier

    Montpellier

  • CH Morlaix

    Morlaix

  • GH de Mulhouse

    Mulhouse

  • CHU Nantes

    Nantes

  • CH Nevers

    Nevers

  • CHU Nice

    Nice

  • CH Niort

    Niort

  • CH Orleans

    Orléans

  • AP-HP Ambroise Pare

    Paris

  • AP-HP Bichat

    Paris

  • AP-HP Lariboisiere

    Paris

  • AP-HP Pitie-Salpetriere

    Paris

  • AP-HP Saint Antoine

    Paris

  • Hopital La Croix Saint Simon

    Paris

  • Hôpital Cochin

    Paris

  • CH Pau

    Pau

  • CHU Reims

    Reims

  • CHU Rouen

    Rouen

  • CHU de la Reunion

    Saint-Denis

  • CHU Saint Etienne

    Saint-Etienne

  • CH Bégin

    Saint-Mandé

  • CH Saint Nazaire

    Saint-Nazaire

  • CHU Strasbourg

    Strasbourg

  • CHU Toulouse

    Toulouse

  • CHU Tours

    Tours

  • CH Troyes

    Troyes

  • CH Valence

    Valence

  • CH Valenciennes

    Valenciennes

  • Polyclinique Vauban

    Valenciennes

Other trials in France

About this study

Official 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."

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.

Read more

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.

Read the detailed description

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.
Being tested
no intervention
Medical subject headings
Arthritis, Rheumatoid, Rheumatic Fever, Arthritis, Psoriatic, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic maintenance of JAK inhibitors

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

    Measured: From the beginning of the study up to Year 1

Secondary outcomes (15)

  1. Real-life tolerance of JAK inhibitors

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

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

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

    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

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

  3. Efficacy of JAK inhibitors

    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.

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

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

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

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

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

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

  6. Use of JAK inhibitors in current practice

    Starting dosage, therapeutic adjustments, etc.

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

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

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

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

  8. Patient reported outcomes: Quality of life

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

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

  9. Patient reported outcomes: Acceptance

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

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

  10. Patient reported outcomes: Compliance

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

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

  11. Drug interactions

    Identify new drug interactions

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

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

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

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

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

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

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

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

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

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

  15. Establishment of an open database

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start8 Oct 2019
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,300 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602091
Sponsor's protocol ID
MAJIK Registry
Acronym
MAJIK
Status last verified
Jan 2025
First submitted
14 Oct 2020
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Triboulet F, Juge PA, Truchetet ME, Pham T, Roux N, Flipo RM, Leske C, Roux CH, Seror R, Basch A, Brocq O, Chazerain P, Coury-Lucas F, Damade R, Dernis E, Gottenberg JE, Ramon A, Ruyssen-Witrand A, Salmon JH, Shipley E, Tournadre A, Prati C, Dieude P, Avouac J. Evaluation of rheumatoid arthritis-associated interstitial lung disease in patients treated with JAK inhibitors: a MAJIK-SFR cohort study. RMD Open. 2025 Jan 6;11(1):e005062. doi: 10.1136/rmdopen-2024-005062.

    PubMed 39762124

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Inflammatory Rheumatism, run by Societe Francaise de Rhumatologie at 60 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic maintenance of JAK inhibitors (time frame: From the beginning of the study up to Year 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04602091, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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