BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Conditions

• Polymyalgia Rheumatic (PMR)

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Baricitinib — DRUG
  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
• Placebos — DRUG
  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

Study Details

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.

Key Dates

Start date

Dec 1, 2020

Status verified

Nov 2023

Primary completion

Aug 30, 2023

Completion

Aug 30, 2023

Study Design

Enrollment

34 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental group
  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.
• Placebo Comparator: Control group
  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.

Primary Outcome Measure

Following of the Polymyalgia Rheumatica Activity score [ Time Frame: 12 weeks ]