Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-24 @ 8:43 PM
Study NCT ID:
NCT02804204
Status:
UNKNOWN
Last Update Posted:
2019-02-07
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-TNF treatment response based on circulant rheumatoid factor', 'timeFrame': '24 weeks'}, {'measure': 'Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis according to the ACR criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Over 18 years old\n* Diagnosis of rheumatoid arthritis according to ACR criteria\n* Patients that initiate treatment with anti-TNF drugs according to clinical practice, both in naïve anti-TNF patients and patients after first anti-TNF failure\n* Patients able to follow the protocol requirements\n* Patients that signed the informed consent\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to investigational products\n* Patients with tuberculosis, or severe infections like sepsis or opportunistic infections\n* Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV)\n* Patients that according to the investigator criteria can not participate in the study or complete the study questionnaires\n* Pregnant or fertile woman that does not use a contraception method'}, 'identificationModule': {'nctId': 'NCT02804204', 'acronym': 'AROMA', 'briefTitle': 'Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'SMB-CZP- 2014-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anti-TNF', 'interventionNames': ['Drug: Anti-TNF']}], 'interventions': [{'name': 'Anti-TNF', 'type': 'DRUG', 'armGroupLabels': ['Anti-TNF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Granada', 'state': 'Andalusia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Enrique Raya', 'role': 'CONTACT'}], 'facility': 'Hospital San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Málaga', 'state': 'Andalusia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Fernandez Nebro', 'role': 'CONTACT'}], 'facility': 'Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'state': 'Andalusia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Povedano', 'role': 'CONTACT'}], 'facility': 'Hospital Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Juan Mas', 'role': 'CONTACT'}], 'facility': 'Hospital Son LLatzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Bilbao', 'state': 'Basque Country', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Luz García', 'role': 'CONTACT'}], 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'San Cristóbal de La Laguna', 'state': 'Canary Islands', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Díaz', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'city': 'Santander', 'state': 'Cantabria', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricardo Blanco', 'role': 'CONTACT'}], 'facility': 'Hospital Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Guadalajara', 'state': 'Castille-La Mancha', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesús Tornero', 'role': 'CONTACT'}], 'facility': 'Hospital de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '08028', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sara Marsal, PhD', 'role': 'CONTACT'}], 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Catalonia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raimon Sanmartí', 'role': 'CONTACT'}], 'facility': 'Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Catalonia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Josep María Llobet', 'role': 'CONTACT'}], 'facility': 'Hospital de Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': "L'Hospitalet de Llobregat", 'state': 'Catalonia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Maymó', 'role': 'CONTACT'}], 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Sant Joan Despí', 'state': 'Catalonia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Hector Corominas', 'role': 'CONTACT'}], 'facility': 'Hospital Moises Broggi', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'city': 'A Coruña', 'state': 'Galicia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Javier Blanco', 'role': 'CONTACT'}], 'facility': 'Complexo Hospitalaria A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricardo Blanco', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Santiago Muñoz', 'role': 'CONTACT'}], 'facility': 'Hospital Infanta Sofía', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alejandro Balsa', 'role': 'CONTACT'}], 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Luis Andreu', 'role': 'CONTACT'}], 'facility': 'Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'state': 'Murcia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Martínez', 'role': 'CONTACT'}], 'facility': 'Hospital Virgen de la Arreixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Sara Marsal, PhD', 'role': 'CONTACT', 'phone': '+34 93 402 90 82'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}