Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04972760
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2021-06-14
Brief Title:
Baricitinib in Patients With Relapsing or naïve Dermatomyositis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Baricitinib in Patients With Relapsing or naïve Dermatomyositis a Multicenter Randomized Controlled Trial BIRD
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIRD
Brief Summary:
Dermatomyositis DM is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events cardiovascular mortality glucocorticoids-induced muscle and skin damages Corticosteroids taper is associated with disease relapses Although there is no evidence from the literature clinical practice guidelines recommends the use of DMARDs such as methotrexate However response is not complete and these DMARDS take time to act
The interferon type I IFN-I pathway is involved in the pathophysiology of DM Janus kinase 1 and 2 transduces IFN-I signals In addition JAK2 inhibition enhances muscle repair and force generation
JAK 12 inhibitors permitted to dramatically and rapidly improve relapsing DM patients n4 case series
Our hypothesis is that Janus kinase 1 and 2 JAK12 inhibitors baricitinib will permit to obtain dermatomyositis DM improvement with a steroid sparing effect as compared to usual care
Our primary objective is to evaluate the efficacy of baricitinib JAK12 inhibitor to obtain prednisone-free moderate improvement ACREULAR 40 of DM as compared to placebo in addition to usual care
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms 11 This is an add-on trial to usual care with rapid corticoid taper
This is a multicenter trial in different medical departments in hospitals across France in different regions
Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM departments of dermatology rheumatology and internal medicine
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events cardiovascular mortality glucocorticoids-induced muscle and skin damages Corticosteroids taper is associated with disease relapses Although there is no evidence from the literature clinical practice guidelines recommends the use of DMARDs such as methotrexate However response is not complete and these DMARDS take time to act
The interferon type I IFN-I pathway is involved in the pathophysiology of DM Janus kinase 1 and 2 transduces IFN-I signals In addition JAK2 inhibition enhances muscle repair and force generation
JAK 12 inhibitors permitted to dramatically and rapidly improve relapsing DM patients n4 case series
Our hypothesis is that Janus kinase 1 and 2 JAK12 inhibitors baricitinib will permit to obtain dermatomyositis DM improvement with a steroid sparing effect as compared to usual care
Our primary objective is to evaluate the efficacy of baricitinib JAK12 inhibitor to obtain prednisone-free moderate improvement ACREULAR 40 of DM as compared to placebo in addition to usual care
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms 11 This is an add-on trial to usual care with rapid corticoid taper
This is a multicenter trial in different medical departments in hospitals across France in different regions
Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM departments of dermatology rheumatology and internal medicine
Detailed Description:
Dermatomyositis DM is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events cardiovascular mortality glucocorticoids-induced muscle and skin damages Corticosteroids taper is associated with disease relapses Although there is no evidence from the literature clinical practice guidelines recommends the use of DMARDs such as methotrexate However response is not complete and these DMARDS take time to actThe interferon type I IFN-I pathway is involved in the pathophysiology of DM Janus kinase 1 and 2 transduces IFN-I signals In addition JAK2 inhibition enhances muscle repair and force generation
JAK 12 inhibitors permitted to dramatically and rapidly improve relapsing DM patients n4 case series
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms 11 This is an add-on trial to usual care with rapid corticoid taper Both groups experimental and control groups will receive corticosteroids and the conventional immunosuppressive drug either azathioprine or methotrexate
Our primary objective is to evaluate the efficacy of baricitinib JAK12 inhibitor to obtain prednisone-free DM moderate improvement as compared to placebo in addition to usual care
Primary endpoint moderate improvement defined as a total improvement score superior or equal to 40 following ACREULAR definition without corticosteroids at week 24 prednisone-free moderate improvement
This multicenter trial involves different medical departments in hospitals across France in different regions Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM departments of dermatology rheumatology and internal medicine
Eligible patients will sign a written informed consent after full oral and written information about the trial They will be randomized in 11 ratio to receive baricitinib plus prednisone taper plus one immunosuppressive drug either methotrexate or azathioprine experimental group or placebo plus prednisone taper plus one immunosuppressive drug either methotrexate or azathioprine control group for a duration of 24 weeks In both groups corticosteroids are tapered following a predefined protocol
5 visits are planned
screening visit W-4 to D-1
baseline visit W0
follow-up visit 1 W5 -5 days
follow-up visit 2 W12 -5 days
end of study visit 3 W24-5 days Data will be collected by investigator and clinical research associate on an electronic case report form eCRF via a web browser
The primary analysis will be the comparison between experimental and control groups of the rate of prednisone-free moderate improvement at 24 weeks in the intent to treat population In order to demonstrate a difference in the rate of primary outcome at 24 weeks from 30 in the control group to 70 in the experimental group with a power of 80 a bilateral alpha risk of 5 and a 15 rate of loss of follow-up 62 patients are necessary
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events cardiovascular mortality glucocorticoids-induced muscle and skin damages Corticosteroids taper is associated with disease relapses Although there is no evidence from the literature clinical practice guidelines recommends the use of DMARDs such as methotrexate However response is not complete and these DMARDS take time to actThe interferon type I IFN-I pathway is involved in the pathophysiology of DM Janus kinase 1 and 2 transduces IFN-I signals In addition JAK2 inhibition enhances muscle repair and force generation
JAK 12 inhibitors permitted to dramatically and rapidly improve relapsing DM patients n4 case series
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms 11 This is an add-on trial to usual care with rapid corticoid taper Both groups experimental and control groups will receive corticosteroids and the conventional immunosuppressive drug either azathioprine or methotrexate
Our primary objective is to evaluate the efficacy of baricitinib JAK12 inhibitor to obtain prednisone-free DM moderate improvement as compared to placebo in addition to usual care
Primary endpoint moderate improvement defined as a total improvement score superior or equal to 40 following ACREULAR definition without corticosteroids at week 24 prednisone-free moderate improvement
This multicenter trial involves different medical departments in hospitals across France in different regions Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM departments of dermatology rheumatology and internal medicine
Eligible patients will sign a written informed consent after full oral and written information about the trial They will be randomized in 11 ratio to receive baricitinib plus prednisone taper plus one immunosuppressive drug either methotrexate or azathioprine experimental group or placebo plus prednisone taper plus one immunosuppressive drug either methotrexate or azathioprine control group for a duration of 24 weeks In both groups corticosteroids are tapered following a predefined protocol
5 visits are planned
screening visit W-4 to D-1
baseline visit W0
follow-up visit 1 W5 -5 days
follow-up visit 2 W12 -5 days
end of study visit 3 W24-5 days Data will be collected by investigator and clinical research associate on an electronic case report form eCRF via a web browser
The primary analysis will be the comparison between experimental and control groups of the rate of prednisone-free moderate improvement at 24 weeks in the intent to treat population In order to demonstrate a difference in the rate of primary outcome at 24 weeks from 30 in the control group to 70 in the experimental group with a power of 80 a bilateral alpha risk of 5 and a 15 rate of loss of follow-up 62 patients are necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004987-24 | EUDRACT_NUMBER | None | None |