Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 6:24 PM
Study NCT ID:
NCT06172361
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2023-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011111', 'term': 'Polymyalgia Rheumatica'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C036266', 'term': 'prednylidene'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment group: Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib\n\nPositive control group: prednisone (or equivalent dose of methylprednisolone)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with PMR-AS score <10 score at weeks 52', 'timeFrame': 'at 52 weeks', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'PMR-AS score at weeks 24', 'timeFrame': 'at 24 weeks', 'description': '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)'}, {'measure': 'PMR-AS score at weeks 52', 'timeFrame': 'at 52 weeks', 'description': '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)'}, {'measure': 'CRP at weeks 24', 'timeFrame': 'at 24 weeks', 'description': 'CRP (mg/dL)'}, {'measure': 'CRP at weeks 52', 'timeFrame': 'at 52 weeks', 'description': 'CRP (mg/dL)'}, {'measure': 'ESR at weeks 24', 'timeFrame': 'at 24 weeks', 'description': 'ESR (mm/h)'}, {'measure': 'ESR at weeks 52', 'timeFrame': 'at 52 weeks', 'description': 'ESR (mm/h)'}, {'measure': 'Proportion of patients who discontinue drugs at weeks 52', 'timeFrame': 'at 52 weeks', 'description': 'Proportion of patients who discontinue Tof in the treatment group, prednisone in the control group at weeks 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polymyalgia Rheumatica', 'Tofacitinib', 'Glucocorticoid'], 'conditions': ['Polymyalgia Rheumatica']}, 'referencesModule': {'references': [{'pmid': '36125471', 'type': 'BACKGROUND', '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.'}, {'pmid': '36604153', 'type': 'BACKGROUND', '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.'}, {'pmid': '37384596', 'type': 'BACKGROUND', '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.'}, {'pmid': '37730835', 'type': 'BACKGROUND', '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.'}, {'pmid': '36828585', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Rheumatic polymyalgia (PMR) is more commonly observed in individuals over the age of 50, who may have a higher prevalence of osteoporosis, diabetes, cardiovascular diseases, and other chronic conditions. Currently, glucocorticoids are the primary treatment for PMR, but they can lead to various side effects, and recurrence is common during steroid tapering. Our previous 24-week study confirmed the effective treatment of PMR patients with tofacitinib. Given the relatively slow efficacy of tofacitinib, early adjunctive therapy with NSAIDs is needed. To address this, we are planning an open-label 52-week randomized controlled trial. This study aims to assess the use of tofacitinib in combination with glucocorticoids to induce rapid improvement, followed by rapid tapering of steroids and slow tapering of tofacitinib. The objective is to observe the efficacy and safety of this regimen for PMR, providing a new treatment option for clinical use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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;\n2. Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) \\> 10,\n3. Adults age 50-88, Weight 45-85Kg,\n4. ESR\\>20mm/h or CRP \\>50mg/L (5mg/dl),\n5. Informed consent.\n\nExclusion Criteria:\n\n1. Patients with known allergies to tofacitinib, prednisone or methylprednisolone,\n2. Patients with identified giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and other rheumatic diseases,\n3. Patients with severe osteoarthritis,\n4. Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.),\n5. Hepatitis B virus carriers or individuals with chronic active hepatitis B or C, other chronic liver diseases, HIV infection,\n6. 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,\n7. Pregnant or lactating women,\n8. 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),\n9. Patients with previous visual field disorder or single eye dysfunction, cataract patients,\n10. 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,\n11. For patients with abnormal blood routine, lymphocytes \\<500/mm3 or ANC \\<1000/mm3 or HGB \\< 90g/L,\n12. Patients with active bleeding and peptic ulcer,\n13. Have used biological agents or added azathioprine, leflunomide, FK 506 within 1 month before enrollment,\n14. Those who have participated in other drug clinical trials within 4 weeks,\n15. Patients using CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, or rifampicin within 4 weeks.'}, 'identificationModule': {'nctId': 'NCT06172361', 'acronym': 'ITTGPMR', 'briefTitle': 'Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IIT20230087C-X1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib', 'interventionNames': ['Drug: Prednisone+Tofacitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control group', 'description': 'prednisone (or equivalent dose of methylprednisolone)', 'interventionNames': ['Drug: Prednisone']}], 'interventions': [{'name': 'Prednisone+Tofacitinib', 'type': 'DRUG', 'otherNames': ['Pred+Tof'], 'description': '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.\n\nTake 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.', 'armGroupLabels': ['Treatment group']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Pred'], 'description': '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.', 'armGroupLabels': ['Positive control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '313000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqian Chen, Doctor', 'role': 'CONTACT', 'email': 'cwq678@zju.edu.cn', 'phone': '+8613989814907'}], 'facility': 'Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yanlin He', 'role': 'CONTACT', 'email': 'yanlinriver@163.com', 'phone': '8617799855659'}], 'overallOfficials': [{'name': 'Weiqian Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Weiqian Chen', 'investigatorAffiliation': 'Zhejiang University'}}}}