Polymyalgia Rheumatica Clinical Trial
— ITTGPMROfficial title:
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
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
Status | Not yet recruiting |
Enrollment | 98 |
Est. completion date | January 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 88 Years |
Eligibility | Inclusion Criteria: 1. PMR patients who fulfilled the 1982 Chuang criteria or 2012ACR/EULAR criteria for PMR; They did not receive any glucocorticoids or biological agents during the 2 weeks period that preceded their inclusion in the study; 2. Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) > 10, 3. Adults age 50-88, Weight 45-85Kg, 4. ESR>20mm/h or CRP >50mg/L (5mg/dl), 5. Informed consent. Exclusion Criteria: 1. Patients with known allergies to tofacitinib, prednisone or methylprednisolone, 2. Patients with identified giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and other rheumatic diseases, 3. Patients with severe osteoarthritis, 4. Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.), 5. Hepatitis B virus carriers or individuals with chronic active hepatitis B or C, other chronic liver diseases, HIV infection, 6. 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, 7. Pregnant or lactating women, 8. 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), 9. Patients with previous visual field disorder or single eye dysfunction, cataract patients, 10. 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, 11. For patients with abnormal blood routine, lymphocytes <500/mm3 or ANC <1000/mm3 or HGB < 90g/L, 12. Patients with active bleeding and peptic ulcer, 13. Have used biological agents or added azathioprine, leflunomide, FK 506 within 1 month before enrollment, 14. Those who have participated in other drug clinical trials within 4 weeks, 15. Patients using CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, or rifampicin within 4 weeks. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
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. 2023 Feb 24:ard-2022-223429. doi: 10.1136/ard-2022-223429. Online ahead of print. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PMR-AS score at weeks 24 | 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]+ ability to elevate the upper limbs(EUL 0-3) | at 24 weeks | |
Secondary | PMR-AS 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 | CRP at weeks 24 | CRP (mg/dL) | at 24 weeks | |
Secondary | CRP at weeks 52 | CRP (mg/dL) | at 52 weeks | |
Secondary | ESR at weeks 24 | ESR (mm/h) | at 24 weeks | |
Secondary | ESR at weeks 52 | ESR (mm/h) | at 52 weeks | |
Secondary | Proportion of patients who discontinue drugs at weeks 52 | Proportion of patients who discontinue Tof in the treatment group, prednisone in the control group at weeks 52 | at 52 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04972968 -
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
|
Phase 2 | |
Active, not recruiting |
NCT04519580 -
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
|
||
Recruiting |
NCT06460142 -
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
|
||
Terminated |
NCT03600818 -
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
|
Phase 3 | |
Completed |
NCT00836810 -
Timed Release Tablet Prednisone in Polymyalgia Rheumatica
|
Phase 2/Phase 3 | |
Completed |
NCT04239521 -
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
|
||
Completed |
NCT03263715 -
A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)
|
Phase 3 | |
Recruiting |
NCT05935709 -
DANIsh VASculitis Database (DANIVAS)
|
||
Not yet recruiting |
NCT02985424 -
Polymyalgia Rheumatica and Giant Cell Arteritis
|
N/A | |
Completed |
NCT00138983 -
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
|
Phase 3 | |
Recruiting |
NCT06130540 -
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR
|
Phase 1 | |
Recruiting |
NCT05767034 -
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
|
Phase 3 | |
Terminated |
NCT01821040 -
A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
|
Phase 3 | |
Recruiting |
NCT00982332 -
Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
|
N/A | |
Recruiting |
NCT05312944 -
Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome
|
||
Recruiting |
NCT04664465 -
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
|
||
Withdrawn |
NCT02899026 -
Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica
|
Phase 3 | |
Recruiting |
NCT03576794 -
Treatment With Leflunomide in Patients With Polymyalgia Rheumatica
|
Phase 3 | |
Completed |
NCT05681676 -
Melanocortin Gene Expression in Lymphocytes of Polymyalgia Patients
|
||
Recruiting |
NCT05435781 -
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
|
Phase 4 |