Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT04264494
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2020-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint 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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-08', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale (VAS).', 'timeFrame': 'Change from baseline to 6 months post injection.', 'description': 'the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)'}, {'measure': 'Inflammatory mediators.', 'timeFrame': 'Change from baseline to 6 months post injection.', 'description': 'By means of ELISA (IL 1 beta and TNF alpha'}, {'measure': 'Health assessment questionnaire disability index. (HAQ-DI)', 'timeFrame': 'Change from baseline to 6 months post injection.', 'description': 'Is a patient reported outcome which is usually self-administered by the patient and scales range from 0 (no difficulty) to 3 (unable to do)'}], 'secondaryOutcomes': [{'measure': 'Disease Activity Score 28(DAS28)', 'timeFrame': 'At baseline,3 and 6 months post injection.', 'description': 'to asses disease activity by measuring the number of tender and swollen joints,patient global assessment and ESR. values range from 2.0 (remission) to 10.0 (higher disease activity).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RA - Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo.', 'detailedDescription': '100 patients with RA fulfilling the 2010 ACR-EULAR classification criteria for RA were recruited from the outpatient clinic of the Rheumatology and Rehabilitation department. All patients were subjected to clinical and laboratory assessment, visual analog score (VAS) scale and Health Assessment Questionnaire (HAQ). Fifty patients were injected intra-articularly with 3 doses of PRP and 50 patients who serve as a control injected with 3 doses of placebo at 4 weeks intervals for the tender joints and revaluated at 1, 3 months post the last injection regarding the same evaluating tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.\n\nExclusion Criteria:\n\n* Patients with Local abscess,\n* systemic illness as (diabetes mellitus, malignancy),\n* patients on opioids analgesics.\n* pregnancy, blood disorders(coagulopathy, thrombocytopenia),'}, 'identificationModule': {'nctId': 'NCT04264494', 'briefTitle': 'Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Evaluating the Role of Intra-articular Injections of Platelet-rich Plasma (PRP) in Patients With Rheumatoid Arthritis and Its Impact on Disease Activity and Quality of Life.', 'orgStudyIdInfo': {'id': '1475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP group', 'description': 'Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints', 'interventionNames': ['Procedure: PRP intra articular injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints.', 'interventionNames': ['Procedure: NACL intra articular injection']}], 'interventions': [{'name': 'PRP intra articular injection', 'type': 'PROCEDURE', 'otherNames': ['PRP Injection.'], 'description': 'Fifty RA patients were injected intra-articularly with 3 doses of PRP at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6 months post the last injection regarding the same evaluating tools.', 'armGroupLabels': ['PRP group']}, {'name': 'NACL intra articular injection', 'type': 'PROCEDURE', 'otherNames': ['Placebo injection(NACL)'], 'description': 'and 50 patients who serve as a control and injected intra-articularly with 3 doses of placebo (NaCl saline) at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6months post last injection regarding the same evaluating tools.', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dalia Saif', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalia Salah Saif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Dalia Salah Saif', 'investigatorAffiliation': 'Menoufia University'}}}}