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

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ClinicalTrials.gov Identifier: NCT04602091
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Bordeaux PharmacoEpi
Information provided by (Responsible Party):
Societe Francaise de Rhumatologie

Brief 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.

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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Inflammatory Rheumatism Psoriatic Arthritis Spondyloarthritis Other: no intervention

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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."
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2029



Intervention Details:
  • Other: no intervention
    no intervention


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
French patients treated for chronic inflammatory rheumatic disorders according to EMA.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602091


Contacts
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Contact: Sorelle MBOUM +33 (0)158413129 majik@rhumatologie.asso.fr

Locations
Show Show 60 study locations
Sponsors and Collaborators
Societe Francaise de Rhumatologie
Bordeaux PharmacoEpi
Investigators
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Principal Investigator: Marie-Elise TRUCHETET CHU de Bordeaux - Pellegrin
Principal Investigator: Jerôme AVOUAC AP-HP Hôpital Cochin
Principal Investigator: Clément PRATI CHRU de Besançon
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Responsible Party: Societe Francaise de Rhumatologie
ClinicalTrials.gov Identifier: NCT04602091    
Other Study ID Numbers: MAJIK Registry
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Rheumatic Fever
Arthritis
Arthritis, Psoriatic
Spondylarthritis
Rheumatic Diseases
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections