Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica

NCT06172361 | Recruiting Phase 3 DMC

• 1 other identifier: IIT20230087C-X1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This will be efficacy and safety of Induction and Tapering Therapy with Tofacitinib and Glucocorticoid in patients with Polymyalgia Rheumatica (ITTG PMR): An open-label 52-week randomized controlled trial

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia Rheumatica; Tofacitinib; Glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with PMR-AS score <10 score at weeks 52

  PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+ EUL (0-3)

  at 52 weeks

Secondary Outcomes (7)

• PMR-AS score at weeks 24

  at 24 weeks

• PMR-AS score at weeks 52

  at 52 weeks

• CRP at weeks 24

  at 24 weeks

• CRP at weeks 52

  at 52 weeks

• ESR at weeks 24

  at 24 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib

Drug: Prednisone+Tofacitinib

Positive control group

ACTIVE COMPARATOR

prednisone (or equivalent dose of methylprednisolone)

Drug: Prednisone

Interventions

Prednisone+Tofacitinib DRUG

Withdrawal of prednisone (or equivalent dose of methylprednisolone) within 4 weeks: 5mg tid for 2 weeks, 5mg bid for 1 week, 5mg qd for 1 week, then discontinue. Take Tofacitinib 10mg/d for 3 months, then 7.5mg/d for 2 months, followed by 5mg qd for 2 months, then 5mg qod for 2 months, and finally 5mg every 3 days for 2 months, discontinue the Tofacitinib for 1 month. If there is a relapse during the dose reduction process, resume Tofacitinib at the original dosage.

Also known as: Pred+Tof

Treatment group

Prednisone DRUG

Prednisone 15mg (or equivalent dose of methylprednisolone) was set as the initial treatment of PMR. When improvement was achieved, the dose of Prednisone was reduced to 10mg daily within 4-10 weeks; When remission was achieved, then taper Prednisone gradually by 2.5mg every 6-8 weeks. Once relapse occurred, the dose increased to the pre-relapse dose. If reducing pred dosage is difficult, Methotrexate (MTX) 10mg qw can be added after 24 weeks.

Also known as: Pred

Positive control group

Eligibility Criteria

• Age: 50 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) \> 10,
• Adults age 50-88, Weight 45-85Kg,
• ESR\>20mm/h or CRP \>50mg/L (5mg/dl),
• Informed consent.

You may not qualify if:

• Patients with known allergies to tofacitinib, prednisone or methylprednisolone,
• Patients with identified giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and other rheumatic diseases,
• Patients with severe osteoarthritis,
• Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.),
• Hepatitis B virus carriers or individuals with chronic active hepatitis B or C, other chronic liver diseases, HIV infection,
• Patients with abnormal liver function (ALT/AST 2 times higher); Moderate to severe renal impairment (glomerular filtration rate \<60); hyperlipidemia not improved by lipid-lowering drugs,
• Pregnant or lactating women,
• Patients with a history of malignancy who do not meet the following condition (patients with malignant tumors who have been successfully treated for more than 5 years before screening without any evidence of recurrence),
• Patients with previous visual field disorder or single eye dysfunction, cataract patients,
• Patients with decompensated cardiac insufficiency or severe hypertension or diabetes mellitus, i.e. systolic blood pressure higher than 160mmhg or diastolic blood pressure higher than 100mmhg,
• For patients with abnormal blood routine, lymphocytes \<500/mm3 or ANC \<1000/mm3 or HGB \< 90g/L,
• Patients with active bleeding and peptic ulcer,
• Have used biological agents or added azathioprine, leflunomide, FK 506 within 1 month before enrollment,
• Those who have participated in other drug clinical trials within 4 weeks,
• Patients using CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, or rifampicin within 4 weeks.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 313000, China

RECRUITING

Related Publications (5)

• Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, Richez C, Truchetet ME, Wendling D, Toussirot E, Perdriger A, Gottenberg JE, Felten R, Fautrel BJ, Chiche L, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Chary-Valckenaere I, Cornec D, Guellec D, Marhadour T, Nowak E, Saraux A. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1053-1062. doi: 10.1001/jama.2022.15459.

  PMID: 36125471 BACKGROUND

• Zhang L, Li J, Yin H, Chen D, Li Y, Gu L, Fu Y, Chen J, Chen Z, Yang S, Ye S, Li T, Lu L. Efficacy and safety of tofacitinib in patients with polymyalgia rheumatica: a phase 2 study. Ann Rheum Dis. 2023 May;82(5):722-724. doi: 10.1136/ard-2022-223562. Epub 2023 Jan 5. No abstract available.

  PMID: 36604153 BACKGROUND

• Ma X, Yang F, Wu J, Xu B, Jiang M, Sun Y, Sun C, Yu Y, Xu D, Xiao L, Ren C, Chen C, Ye Z, Liang J, Lin J, Chen W. Efficacy and Safety of Tofacitinib in Patients with Polymyalgia Rheumatica (EAST PMR): An open-label randomized controlled trial. PLoS Med. 2023 Jun 29;20(6):e1004249. doi: 10.1371/journal.pmed.1004249. eCollection 2023 Jun.

  PMID: 37384596 BACKGROUND

• Spinelli FR, Garufi C, Mancuso S, Ceccarelli F, Truglia S, Conti F. Tapering and discontinuation of glucocorticoids in patients with rheumatoid arthritis treated with tofacitinib. Sci Rep. 2023 Sep 20;13(1):15537. doi: 10.1038/s41598-023-42371-z.

  PMID: 37730835 BACKGROUND

• Dejaco C, Kerschbaumer A, Aletaha D, Bond M, Hysa E, Camellino D, Ehlers L, Abril A, Appenzeller S, Cid MC, Dasgupta B, Duftner C, Grayson PC, Hellmich B, Hocevar A, Kermani TA, Matteson EL, Mollan SP, Neill L, Ponte C, Salvarani C, Sattui SE, Schmidt WA, Seo P, Smolen JS, Thiel J, Toro-Gutierrez CE, Whitlock M, Buttgereit F. Treat-to-target recommendations in giant cell arteritis and polymyalgia rheumatica. Ann Rheum Dis. 2024 Jan 2;83(1):48-57. doi: 10.1136/ard-2022-223429.

  PMID: 36828585 BACKGROUND

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Prednisone; prednylidene

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Weiqian Chen

  Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanlin He

CONTACT

8617799855659; yanlinriver@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Treatment group: Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib Positive control group: prednisone (or equivalent dose of methylprednisolone)

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 20, 2024
• Primary Completion: September 30, 2025
• Study Completion: January 30, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)