Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT03533569
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2018-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected for protein and DNA analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-04-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-05-10', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months', 'timeFrame': 'Baseline (Visit 1) and 3 months after treatment (Visit 2)', 'description': 'Pain outcome measure. The Numerical Rating Scale for pain has a range of 0 - 10, with the lowest score being 0 and the highest rating at 10.The pain rating will be reported by the participants for their symptomatic knee'}], 'secondaryOutcomes': [{'measure': 'Change in Biomarkers 3 months following treatment', 'timeFrame': 'Baseline (Visit 1) and 3 months after treatment (Visit 2)', 'description': 'Protein measurements in serum, urine and synovial fluid for type II collagen degradation products in the samples. The levels of type II collagen degradation products may range from 0 to greater than 500 ng/mmol, depending on the stage and severity of the condition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'inflammation'], 'conditions': ['Osteoarthritis, Knee', 'Rheumatoid Arthritis', 'Spondyloarthritis', 'Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. In this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. Markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.', 'detailedDescription': 'Osteoarthritis (OA) is the most common form of arthritis worldwide. OA causes major disability and pain and places a huge financial burden on healthcare worldwide. In recent work, the gene expression profile of bone marrow lesions (BML) in osteoarthritis has been evaluated. BML in OA have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. The plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee OA and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis.\n\nA study amendment was added in April 2020 due to Covid-19. We are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. We will be evaluating the course of Covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes participants with an established diagnosis of knee osteoarthritis, rheumatoid arthritis, spondyloarthritis or psoriatic arthritis. A control group without arthritis or knee pain serves as the comparator group', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria for OA patients:\n\n* Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis\n* Symptomatic knee pain\n* On usual care for knee osteoarthritis including paracetamol and/or NSAIDs\n\nInclusion criteria for Inflammatory Arthritis Patients:\n\n* Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies \\& Rheumatoid Factor checked ), psoriatic arthritis or spondyloarthropathy\n* Symptomatic knee pain\n* On usual care for arthritis including disease-modifying anti-rheumatic drugs (DMARDs), paracetamol and/or NSAIDs\n\nExclusion Criteria:\n\n* Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome\n* History of uncontrolled depression\n* Recent surgery\n* Uncontrolled ischaemic heart disease\n* Uncontrolled diabetes mellitus\n* Alcohol consumption \\> 14 units/week as per UK National guidelines\n* Participants unable to give full informed consent"}, 'identificationModule': {'nctId': 'NCT03533569', 'acronym': 'ARPAIN', 'briefTitle': 'Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis (ARPAIN) Study', 'orgStudyIdInfo': {'id': '17.0192'}, 'secondaryIdInfos': [{'id': '17/LO/1894', 'type': 'OTHER', 'domain': 'Integrated Research Application System (UK)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Osteoarthritis', 'description': 'Participants with an established diagnosis of knee osteoarthritis', 'interventionNames': ['Procedure: Intra-articular corticosteroid injection']}, {'label': 'Rheumatoid arthritis', 'description': 'Participants with an established diagnosis of rheumatoid arthritis', 'interventionNames': ['Procedure: Intra-articular corticosteroid injection']}, {'label': 'Spondyloarthritis or psoriatic arthritis', 'description': 'Participants with an established diagnosis of spondyloarthritis or psoriatic arthritis', 'interventionNames': ['Procedure: Intra-articular corticosteroid injection']}, {'label': 'Case controls', 'description': 'Participants with no arthritis or knee pain as controls'}], 'interventions': [{'name': 'Intra-articular corticosteroid injection', 'type': 'PROCEDURE', 'description': 'Participants with arthritis will undergo usual care with knee synovial fluid aspiration followed by intra-articular corticosteroid injection', 'armGroupLabels': ['Osteoarthritis', 'Rheumatoid arthritis', 'Spondyloarthritis or psoriatic arthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0RE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Abiola Ms Harrison, BSc', 'role': 'CONTACT', 'email': 'oharriso@sgul.ac.uk', 'phone': '4402082666474'}, {'name': 'Nidhi Dr Sofat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St George's Healthcare NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Nidhi Dr Sofat, MD, PhD', 'role': 'CONTACT', 'email': 'nsofat@sgul.ac.uk', 'phone': '4402087250042'}, {'name': 'Abiola Ms Harrison, BSc', 'role': 'CONTACT', 'email': 'oharriso@sgul.ac.uk', 'phone': '4402082666474'}], 'overallOfficials': [{'name': 'Nidhi Dr Sofat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's, University of London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All data will be published and open access after completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}, {'name': 'Rosetrees Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}