Early Rheumatoid ArthritisIRACNCT03389711
INCMNSZ - Rheumatoid Arthritis Cohort
An observational study of Early Rheumatoid Arthritis and Rheumatoid Arthritis, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial summary
Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Rheumatoid Arthritis, Rheumatoid Arthritis
- What is being tested?
- DMARD´s and multidisciplinary treatment
- How many people
- 237 participants
- Where
- 1 siteMexico
- Study dates
- 4 Feb 2004to 4 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) belongs to the National Institutes of Health of México. Patients enrolled in the Early arthritis cohort had a disease duration of <1 year when first evaluated, and no specific rheumatic diagnosis except for RA. Patients had partial health coverage and paid for their physician's consultations, laboratory investigations and for their treatment that was prescribed by the rheumatologist in charge of the clinic, and was "treat to target" oriented.
Who may be able to join
- Patients ≥18 years old
- Fulfilled ACR 1987 classification criteria for RA
- Disease evolution of <1 year when first evaluated, and no specific rheumatic diagnosis except for RA.
Who cannot join
- Patients with another rheumatic disease, except Sjögren syndrome.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, 14080
Virginia Pascual, MD, virtichu@gmail.com
About this study
Official title: INCMNSZ Early Rheumatoid Arthritis Cohort
Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status.
Read the detailed description
- Provide an standardized follow up by a multidisciplinary specialized team.
- Create a biological (blood) bank to develop future research projects.
- Create a database with the clinical, serologic, radiographic and functional status patients data.
- Define comorbidities and mortality causes.
- Begin an educational program to improve patient disease self-knowledge
- Conditions
- Early Rheumatoid Arthritis, Rheumatoid Arthritis
- Being tested
- DMARD´s and multidisciplinary treatment
- Keywords
- Rheumatoid Arthritis Mexico, Early Rheumatoid Arthritis Cohort Mexico
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMARD´s and multidisciplinary treatmentCombination product
At study enrollment, medical history, disease-specific autoantibodies, ACR 1987 classification criteria for RA were applied. Medical evaluations were standardized and included at least 66 swollen and 68 tender joint counts, acute reactant-phase determinations , patient and physician reported outcomes, comorbidity established by record review, and treatment assessments (name, dose and schedule of all drug they were taking) along with an evaluation of persistence, at six-month intervals.
Patients were evaluated by a single rheumatologist every two months during the first two years of follow-up, and every two, four or six months thereafter.
Also the following scores: Michigan Hand Outcome Questionnaire (MHQ), Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH),Mayor Depressive Episodes (MDE) was defined using the Mini International Neuropsychiatric Interview and the severity of depressive symptoms was assessed with the Beck Depression Inventory (BDI-II).
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity status
Describe the disease activity score using DAS 28 ESR
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Secondary outcomes (7)
Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie)
To describe the changes in every visit in the HAQ score
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index)
To describe the changes in every visit in the RADAI score
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey)
To describe the changes in every visit in the SF-36 score
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Predictors of health care drop-out
Identify and describe patients from an inception ongoing cohort with recent onset RA at inclusion, who dropped out of health care during their follow-up
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Mayor Depressive Episodes (MDE)
Investigate associations between major depressive episodes (MDE), concordance with therapy (CwT) and disease outcomes in rheumatoid arthritis patients.
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Michigan Hand Outcome Questionnarie (MHQ
To assess a variety of hand and upper extremity injuries related to Rheumatoid Arthritis
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH)
To measure upper-extremity disability and symptoms
Measured: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start4 Feb 2004
- Primary completion4 Feb 2024 (estimated)
- Study completion4 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Early Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Virginia Pascual, MD, Principal investigator, INCMNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389711
- Sponsor's protocol ID
- IRE-274-10/11-1
- Acronym
- IRAC
- Status last verified
- Aug 2021
- First submitted
- 14 Dec 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is undecided yet.
Publications
Contreras-Yanez I, Pascual-Ramos V. Predictors of health care drop-out in an inception cohort of patients with early onset rheumatoid arthritis. BMC Musculoskelet Disord. 2017 Jul 28;18(1):321. doi: 10.1186/s12891-017-1670-6.
PubMed 28754110Contreras-Yanez I, Guaracha-Basanez G, Ruiz-Dominguez D, Pascual-Ramos V. Patient's perspective of sustained remission in rheumatoid arthritis. BMC Musculoskelet Disord. 2017 Sep 2;18(1):379. doi: 10.1186/s12891-017-1717-8.
PubMed 28865423Romero-Guzman AK, Menchaca-Tapia VM, Contreras-Yanez I, Pascual-Ramos V. Patient and physician perspectives of hand function in a cohort of rheumatoid arthritis patients: the impact of disease activity. BMC Musculoskelet Disord. 2016 Sep 15;17:392. doi: 10.1186/s12891-016-1246-x.
PubMed 27628666Atisha-Fregoso Y, Lima G, Pascual-Ramos V, Banos-Pelaez M, Fragoso-Loyo H, Jakez-Ocampo J, Contreras-Yanez I, Llorente L. Rheumatoid Arthritis Disease Activity Is Determinant for ABCB1 and ABCG2 Drug-Efflux Transporters Function. PLoS One. 2016 Jul 21;11(7):e0159556. doi: 10.1371/journal.pone.0159556. eCollection 2016.
PubMed 27442114Contreras-Yanez I, Pascual-Ramos V. Window of opportunity to achieve major outcomes in early rheumatoid arthritis patients: how persistence with therapy matters. Arthritis Res Ther. 2015 Jul 11;17(1):177. doi: 10.1186/s13075-015-0697-z.
PubMed 26162892Galicia-Hernandez G, Parra-Salcedo F, Ugarte-Martinez P, Contreras-Yanez I, Ponce-de-Leon A, Pascual-Ramos V. Sustained moderate-to-high disease activity and higher Charlson score are predictors of incidental serious infection events in RA patients treated with conventional disease-modifying anti-rheumatic drugs: a cohort study in the treat-to-target era. Clin Exp Rheumatol. 2016 Mar-Apr;34(2):261-9. Epub 2016 Mar 3.
PubMed 26939612Parra-Salcedo F, Contreras-Yanez I, Elias-Lopez D, Aguilar-Salinas CA, Pascual-Ramos V. Prevalence, incidence and characteristics of the metabolic syndrome (MetS) in a cohort of Mexican Mestizo early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs: the complex relationship between MetS and disease activity. Arthritis Res Ther. 2015 Feb 20;17(1):34. doi: 10.1186/s13075-015-0549-x.
PubMed 25889060Cabrera-Marroquin R, Contreras-Yanez I, Alcocer-Castillejos N, Pascual-Ramos V. Major depressive episodes are associated with poor concordance with therapy in rheumatoid arthritis patients: the impact on disease outcomes. Clin Exp Rheumatol. 2014 Nov-Dec;32(6):904-13. Epub 2014 Sep 5.
PubMed 25190569Sanchez T, Contreras-Yanez I, Elias-Lopez D, Aguilar Salinas CA, Pascual-Ramos V. Prevalence of lipid phenotypes, serum lipid behaviour over follow-up and predictors of serum lipid levels in a cohort of Mexican Mestizo early rheumatoid arthritis patients treated with conventional disease-modifying anti-rheumatic drugs. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):509-15. Epub 2014 Jul 8.
PubMed 25005131Pascual-Ramos V, Contreras-Yanez I, Rivera-Hoyos P, Enriquez L, Ramirez-Anguiano J. Cumulative disease activity predicts incidental hearing impairment in patients with rheumatoid arthritis (RA). Clin Rheumatol. 2014 Mar;33(3):315-21. doi: 10.1007/s10067-014-2485-6. Epub 2014 Jan 18.
PubMed 24435352Pascual-Ramos V, Contreras-Yanez I. Motivations for inadequate persistence with disease modifying anti-rheumatic drugs in early rheumatoid arthritis: the patient's perspective. BMC Musculoskelet Disord. 2013 Dec 1;14:336. doi: 10.1186/1471-2474-14-336.
PubMed 24289729Contreras-Yanez I, Rull-Gabayet M, Vazquez-Lamadrid J, Pascual-Ramos V. Radiographic outcome in Hispanic early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs. Eur J Radiol. 2011 Aug;79(2):e52-7. doi: 10.1016/j.ejrad.2011.03.036. Epub 2011 Apr 8.
PubMed 21477956Contreras-Yanez I, Ponce De Leon S, Cabiedes J, Rull-Gabayet M, Pascual-Ramos V. Inadequate therapy behavior is associated to disease flares in patients with rheumatoid arthritis who have achieved remission with disease-modifying antirheumatic drugs. Am J Med Sci. 2010 Oct;340(4):282-90. doi: 10.1097/MAJ.0b013e3181e8bcb0.
PubMed 20881757Pascual-Ramos V, Contreras-Yanez I, Cabiedes-Contreras J, Rull-Gabayet M, Villa AR, Vazquez-Lamadrid J, Mendoza-Ruiz JJ. Hypervascular synovitis and American College of Rheumatology Classification Criteria as predictors of radiographic damage in early rheumatoid arthritis. Ultrasound Q. 2009 Mar;25(1):31-8. doi: 10.1097/RUQ.0b013e3181981df0.
PubMed 19276959Pascual-Ramos V, Contreras-Yanez I, Villa AR, Cabiedes J, Rull-Gabayet M. Medication persistence over 2 years of follow-up in a cohort of early rheumatoid arthritis patients: associated factors and relationship with disease activity and with disability. Arthritis Res Ther. 2009;11(1):R26. doi: 10.1186/ar2620. Epub 2009 Feb 19.
PubMed 19228421
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCMNSZ Early Rheumatoid Arthritis Cohort
- ClinicalTrials.gov ID
- NCT03389711
- Acronym / sponsor ID
- IRAC / IRE-274-10/11-1
- Conditions
- Early Rheumatoid Arthritis, Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis Mexico, Early Rheumatoid Arthritis Cohort Mexico
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 4 Feb 2004 (actual)
- Primary completion
- 4 Feb 2024 (estimated)
- Study completion
- 4 Feb 2024 (estimated)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status.
Detailed description
- Provide an standardized follow up by a multidisciplinary specialized team.
- Create a biological (blood) bank to develop future research projects.
- Create a database with the clinical, serologic, radiographic and functional status patients data.
- Define comorbidities and mortality causes.
- Begin an educational program to improve patient disease self-knowledge
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) belongs to the National Institutes of Health of México. Patients enrolled in the Early arthritis cohort had a disease duration of <1 year when first evaluated, and no specific rheumatic diagnosis except for RA. Patients had partial health coverage and paid for their physician's consultations, laboratory investigations and for their treatment that was prescribed by the rheumatologist in charge of the clinic, and was "treat to target" oriented.
Key inclusion criteria (3 listed)
- Patients ≥18 years old
- Fulfilled ACR 1987 classification criteria for RA
- Disease evolution of <1 year when first evaluated, and no specific rheumatic diagnosis except for RA.
Key exclusion criteria (1 listed)
- Patients with another rheumatic disease, except Sjögren syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMARD´s and multidisciplinary treatmentAt study enrollment, medical history, disease-specific autoantibodies, ACR 1987 classification criteria for RA were applied. Medical evaluations were standardized and included at least 66 swollen and 68 tender joint counts, acute reactant-phase determinations , patient and physician reported outcomes, comorbidity established by record review, and treatment assessments (name, dose and schedule of all drug they were taking) along with an evaluation of persistence, at six-month intervals. Patients were evaluated by a single rheumatologist every two months during the first two years of follow-up, and every two, four or six months thereafter. Also the following scores: Michigan Hand Outcome Questionnaire (MHQ), Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH),Mayor Depressive Episodes (MDE) was defined using the Mini International Neuropsychiatric Interview and the severity of depressive symptoms was assessed with the Beck Depression Inventory (BDI-II). | Combination product | – |
Primary outcome
Disease activity status
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Describe the disease activity score using DAS 28 ESR
7 secondary outcomes
Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie)
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index)
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey)
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Predictors of health care drop-out
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Mayor Depressive Episodes (MDE)
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Michigan Hand Outcome Questionnarie (MHQ
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH)
Time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Results publication: PubMed 28754110Contreras-Yanez I, Pascual-Ramos V. Predictors of health care drop-out in an inception cohort of patients with early onset rheumatoid arthritis. BMC Musculoskelet Disord. 2017 Jul 28;18(1):321. doi: 10.1186/s12891-017-1670-6.
- Results publication: PubMed 28865423Contreras-Yanez I, Guaracha-Basanez G, Ruiz-Dominguez D, Pascual-Ramos V. Patient's perspective of sustained remission in rheumatoid arthritis. BMC Musculoskelet Disord. 2017 Sep 2;18(1):379. doi: 10.1186/s12891-017-1717-8.
- Results publication: PubMed 27628666Romero-Guzman AK, Menchaca-Tapia VM, Contreras-Yanez I, Pascual-Ramos V. Patient and physician perspectives of hand function in a cohort of rheumatoid arthritis patients: the impact of disease activity. BMC Musculoskelet Disord. 2016 Sep 15;17:392. doi: 10.1186/s12891-016-1246-x.
- Results publication: PubMed 27442114Atisha-Fregoso Y, Lima G, Pascual-Ramos V, Banos-Pelaez M, Fragoso-Loyo H, Jakez-Ocampo J, Contreras-Yanez I, Llorente L. Rheumatoid Arthritis Disease Activity Is Determinant for ABCB1 and ABCG2 Drug-Efflux Transporters Function. PLoS One. 2016 Jul 21;11(7):e0159556. doi: 10.1371/journal.pone.0159556. eCollection 2016.
- Results publication: PubMed 26162892Contreras-Yanez I, Pascual-Ramos V. Window of opportunity to achieve major outcomes in early rheumatoid arthritis patients: how persistence with therapy matters. Arthritis Res Ther. 2015 Jul 11;17(1):177. doi: 10.1186/s13075-015-0697-z.
- Results publication: PubMed 26939612Galicia-Hernandez G, Parra-Salcedo F, Ugarte-Martinez P, Contreras-Yanez I, Ponce-de-Leon A, Pascual-Ramos V. Sustained moderate-to-high disease activity and higher Charlson score are predictors of incidental serious infection events in RA patients treated with conventional disease-modifying anti-rheumatic drugs: a cohort study in the treat-to-target era. Clin Exp Rheumatol. 2016 Mar-Apr;34(2):261-9. Epub 2016 Mar 3.
- Results publication: PubMed 25889060Parra-Salcedo F, Contreras-Yanez I, Elias-Lopez D, Aguilar-Salinas CA, Pascual-Ramos V. Prevalence, incidence and characteristics of the metabolic syndrome (MetS) in a cohort of Mexican Mestizo early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs: the complex relationship between MetS and disease activity. Arthritis Res Ther. 2015 Feb 20;17(1):34. doi: 10.1186/s13075-015-0549-x.
- Results publication: PubMed 25190569Cabrera-Marroquin R, Contreras-Yanez I, Alcocer-Castillejos N, Pascual-Ramos V. Major depressive episodes are associated with poor concordance with therapy in rheumatoid arthritis patients: the impact on disease outcomes. Clin Exp Rheumatol. 2014 Nov-Dec;32(6):904-13. Epub 2014 Sep 5.
- Results publication: PubMed 25005131Sanchez T, Contreras-Yanez I, Elias-Lopez D, Aguilar Salinas CA, Pascual-Ramos V. Prevalence of lipid phenotypes, serum lipid behaviour over follow-up and predictors of serum lipid levels in a cohort of Mexican Mestizo early rheumatoid arthritis patients treated with conventional disease-modifying anti-rheumatic drugs. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):509-15. Epub 2014 Jul 8.
- Results publication: PubMed 24435352Pascual-Ramos V, Contreras-Yanez I, Rivera-Hoyos P, Enriquez L, Ramirez-Anguiano J. Cumulative disease activity predicts incidental hearing impairment in patients with rheumatoid arthritis (RA). Clin Rheumatol. 2014 Mar;33(3):315-21. doi: 10.1007/s10067-014-2485-6. Epub 2014 Jan 18.
- Results publication: PubMed 24289729Pascual-Ramos V, Contreras-Yanez I. Motivations for inadequate persistence with disease modifying anti-rheumatic drugs in early rheumatoid arthritis: the patient's perspective. BMC Musculoskelet Disord. 2013 Dec 1;14:336. doi: 10.1186/1471-2474-14-336.
- Results publication: PubMed 21477956Contreras-Yanez I, Rull-Gabayet M, Vazquez-Lamadrid J, Pascual-Ramos V. Radiographic outcome in Hispanic early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs. Eur J Radiol. 2011 Aug;79(2):e52-7. doi: 10.1016/j.ejrad.2011.03.036. Epub 2011 Apr 8.
- Individual participant dataSharing planned: No. It is undecided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Pascual, MD principal investigator
INCMNSZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Rheumatoid Arthritis and Rheumatoid Arthritis, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia Pascual, MD (00525555734111, virtichu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity status (time frame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389711, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.