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BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR)

Primary Purpose

Polymyalgia Rheumatic (PMR)

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Baricitinib
Placebos
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatic (PMR)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 50 years of age
  • Fulfilling ACR/EULAR criteria for PMR
  • Disease duration ≤6 months
  • No oral or parenteral steroid since ≥ 2 weeks prior to randomization
  • PMR-AS >17
  • Absence of connective tissue diseases or vasculitis
  • Able to give informed consent

Exclusion Criteria:

  • Clinical symptoms of giant cell arteritis
  • Uncontrolled high blood pressure or cardiovascular disease
  • Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
  • Planned major surgical procedure during the study.
  • History of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease).
  • Current active uncontrolled infection
  • Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol

Sites / Locations

  • Chu Bordeaux
  • CHU BrestRecruiting
  • CH Le MansRecruiting
  • CHU Montpellier
  • Ch Morlaix
  • CHU NiceRecruiting
  • CHU StrasbourgRecruiting
  • Chu Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Oral baricitinib 4mg/day for 12 weeks. Then, at week 12, if PMR-AS≤10, patients will receive baricitinib 2 mg for 12 weeks. If PMR-AS ≤10, the patients will not receive any treatment until W24 At W24, if PMR-AS>10, they will receive GCs according to the PMR-AS (PMR-AS<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) according to investigator's opinion.

Oral placebo every day during 3 months (W12). Then, at week 12, if PMR-AS ≤10, placebo for 12 weeks. If PMR-AS ≤10, the patients do not receive any treatment until a flare. If PMR-AS>10, they will receive GCs according to the PMR-AS (PMR-AS<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1mg every week) or increased according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) and according to investigator's opinion.

Outcomes

Primary Outcome Measures

Following of the Polymyalgia Rheumatica Activity score
The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)

Secondary Outcome Measures

Following of the Polymyalgia Rheumatica Activity score
The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)
Emergence of adverse events (Safety and tolerability)
The safety is evaluated with the adverse events in both arms
Following of the cumulative dosages of Glucocorticoids
dosages of GCs
ultrasound of synovitis and tenosynovitis
ultrasound scoring of synovitis and tenosynovitis
Level of biological markers
Level of biological markers and cell subpopulations (Interleukin, cytokines, immune cells) by result of blood test is evaluated.
Following of the quality of life
The Short Form 36 (SF36) is used to evaluate the quality of life. The SF36 scale includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue].
Following of the quality of life
The Hospital Anxiety and the Depression scale (HAD) is used to evaluate the quality of life. The HAD scale has 14 items rated from 0 to 3 with 7 questions relate to anxiety and 7 others to the depressive dimension.
Following of the quality of life
The scale EuroQol 5 dimensions (EDQ5) is used to evaluate the quality of life. The EQ-5D scale is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal, whih is divided by the EQ-5D descriptive system (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the EQ Visual Analogue scale (EQ VAS). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).

Full Information

First Posted
May 16, 2019
Last Updated
January 14, 2022
Sponsor
University Hospital, Brest
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04027101
Brief Title
BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
Acronym
BACHELOR
Official Title
BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included. Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment. No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion. From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatic (PMR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter double blinded randomized placebo controlled trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Oral baricitinib 4mg/day for 12 weeks. Then, at week 12, if PMR-AS≤10, patients will receive baricitinib 2 mg for 12 weeks. If PMR-AS ≤10, the patients will not receive any treatment until W24 At W24, if PMR-AS>10, they will receive GCs according to the PMR-AS (PMR-AS<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) according to investigator's opinion.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Oral placebo every day during 3 months (W12). Then, at week 12, if PMR-AS ≤10, placebo for 12 weeks. If PMR-AS ≤10, the patients do not receive any treatment until a flare. If PMR-AS>10, they will receive GCs according to the PMR-AS (PMR-AS<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1mg every week) or increased according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) and according to investigator's opinion.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Intervention Description
patient will take a tablet of 4 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
patient will take a tablet of 4 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12
Primary Outcome Measure Information:
Title
Following of the Polymyalgia Rheumatica Activity score
Description
The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Following of the Polymyalgia Rheumatica Activity score
Description
The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)
Time Frame
36 weeks
Title
Emergence of adverse events (Safety and tolerability)
Description
The safety is evaluated with the adverse events in both arms
Time Frame
36 weeks
Title
Following of the cumulative dosages of Glucocorticoids
Description
dosages of GCs
Time Frame
36 weeks
Title
ultrasound of synovitis and tenosynovitis
Description
ultrasound scoring of synovitis and tenosynovitis
Time Frame
24 weeks
Title
Level of biological markers
Description
Level of biological markers and cell subpopulations (Interleukin, cytokines, immune cells) by result of blood test is evaluated.
Time Frame
24 weeks
Title
Following of the quality of life
Description
The Short Form 36 (SF36) is used to evaluate the quality of life. The SF36 scale includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue].
Time Frame
36 weeks
Title
Following of the quality of life
Description
The Hospital Anxiety and the Depression scale (HAD) is used to evaluate the quality of life. The HAD scale has 14 items rated from 0 to 3 with 7 questions relate to anxiety and 7 others to the depressive dimension.
Time Frame
36 weeks
Title
Following of the quality of life
Description
The scale EuroQol 5 dimensions (EDQ5) is used to evaluate the quality of life. The EQ-5D scale is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal, whih is divided by the EQ-5D descriptive system (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the EQ Visual Analogue scale (EQ VAS). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 50 years of age Fulfilling ACR/EULAR criteria for PMR Disease duration ≤6 months No oral or parenteral steroid since ≥ 2 weeks prior to randomization PMR-AS >17 Absence of connective tissue diseases or vasculitis Able to give informed consent Exclusion Criteria: Clinical symptoms of giant cell arteritis Uncontrolled high blood pressure or cardiovascular disease Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR Planned major surgical procedure during the study. History of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease). Current active uncontrolled infection Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Saraux, PUPH
Phone
0298347264
Ext
+33
Email
alain.saraux@chu-brest.fr
Facility Information:
Facility Name
Chu Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe RICHEZ, PUPH
Email
christophe.richez@chu-bordeaux.fr
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain SARAUX, PUPH
Email
alain.saraux@chu-brest.fr
Facility Name
CH Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle DERNIS, Dr
Email
edernis@ch-lemans.fr
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques MOREL
Email
j-morel@chu-montpellier.fr
Facility Name
Ch Morlaix
City
Morlaix
ZIP/Postal Code
29672
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine LE HENAFF
Email
clehenaff@ch-morlaix.fr
Facility Name
CHU Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian ROUX
Email
roux.c2@chu-nice.fr
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques-Eric GOTTENBERG
Email
jacques-eric.gottenberg@chru-strasbourg.fr
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo CARVAJAL ALEGRIA, DR
Email
G.CARVAJALALEGRIA@chu-tours.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Learn more about this trial

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

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