Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-06 @ 1:21 AM
Study NCT ID:
NCT00667758
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2008-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-03', 'studyFirstSubmitDate': '2008-04-24', 'studyFirstSubmitQcDate': '2008-04-25', 'lastUpdatePostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group', 'timeFrame': 'From baseline to day 5'}], 'secondaryOutcomes': [{'measure': 'Change in DAS28 (CRP/ESR)', 'timeFrame': 'From baseline to day 2/5 /10/15'}, {'measure': 'Change in anti-CCP level', 'timeFrame': 'From baseline to day 2/5/10/15'}, {'measure': 'Change in cytokine level', 'timeFrame': 'From baseline to day 2/5/10/15'}, {'measure': 'Change in ACR core set measures', 'timeFrame': 'From baseline to day 2/5/10/15'}, {'measure': 'Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders', 'timeFrame': 'Baseilne to day 2/5/10/15'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline up to day 15', 'description': 'Number of patients with adverse events (and serious adverse events) up to day 15 in each group'}, {'measure': 'Proportion of patients with DAS28low disease activity/remission', 'timeFrame': 'Baseline to day 2/5/10/15'}, {'measure': 'Change in HAQ scores', 'timeFrame': 'From baseline to day 5/10/15'}, {'measure': 'Correlation between percent changes in hormones, disease activity and biomarkers', 'timeFrame': 'By day 2, 5, 10 and 15', 'description': 'This endpoint is not directly related to clinical efficacy. Hormones include LH, FSH, oestradiol, testosterone,and cortisol. Biomarkers include immunologic markers, bone markers and cardiovascular markers. This secondary endpoint was sent to authorities during the study before unblinding.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26460564', 'type': 'DERIVED', 'citation': 'Kass A, Hollan I, Fagerland MW, Gulseth HC, Torjesen PA, Forre OT. Rapid Anti-Inflammatory Effects of Gonadotropin-Releasing Hormone Antagonism in Rheumatoid Arthritis Patients with High Gonadotropin Levels in the AGRA Trial. PLoS One. 2015 Oct 13;10(10):e0139439. doi: 10.1371/journal.pone.0139439. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult between 18 years and above\n* Moderate to severe disease activity\n* Negative pregnancy test for women of childbearing potential\n* Use of reliable method of contraception (non-hormonal) by sexually active female patients\n\nExclusion Criteria:\n\n* Patients who are pregnant or breastfeeding\n* Patients taking biologic therapy or prednisolone \\>7.5mg'}, 'identificationModule': {'nctId': 'NCT00667758', 'acronym': 'AGRA', 'briefTitle': 'Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Betanien Hospital'}, 'officialTitle': 'Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'R1/05'}, 'secondaryIdInfos': [{'id': '2007/2/0174', 'type': 'OTHER_GRANT', 'domain': 'Norwegian Foundation for Health and Rehabilitation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cetrorelix', 'interventionNames': ['Drug: Cetrorelix']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'NaCl solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cetrorelix', 'type': 'DRUG', 'description': '3-5 mg s.c. on days 1-5', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3-5 ml NaCl s.c. on days 1-5', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Skien', 'country': 'Norway', 'facility': 'Deaprtment of Rheumatology, Betanien Hospital', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}], 'overallOfficials': [{'name': 'Kåss', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betanien Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Foundation for Health and Rehabilitation', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Anita Kåss', 'investigatorFullName': 'Anita Kass', 'investigatorAffiliation': 'Betanien Hospital'}}}}