RheumatoId Arthritis Clinical Trial
Official title:
Clinical Follow-up of Anti-Carbamylated Antibody Status in Rheumatoid Arthritis Patients at 6, 12 and 18 Months
NCT number | NCT02958319 |
Other study ID # | RE16-00001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | November 26, 2018 |
Verified date | December 2021 |
Source | Universidad Autonoma de Nuevo Leon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients with rheumatoid arthritis (RA) with positive antibodies against carbamylated proteins (anti-CarP) have a more severe clinical course. The primary objective of this study in adult subject with RA is as follows: To explore the clinical differences in activity indexes (Disease Activity Score of 28 joints with Erythro Sedimentaion Rate (DAS28-ESR)) at 6, 12 and 18 months of follow up according the anti-CarP antibodies status.
Status | Completed |
Enrollment | 278 |
Est. completion date | November 26, 2018 |
Est. primary completion date | November 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Rheumatoid arthritis patients according to ACR EULAR 2010 classification that accepted and signed informed consent Exclusion Criteria: - Chronic kidney disease and pregnant patients |
Country | Name | City | State |
---|---|---|---|
Mexico | Servicio de Reumatología, Departamento de Medicina Interna, Facultad de Medicina y Hospital Universitario, Universidad Autonoma de Nuevo León | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Nuevo Leon |
Mexico,
Mydel P, Wang Z, Brisslert M, Hellvard A, Dahlberg LE, Hazen SL, Bokarewa M. Carbamylation-dependent activation of T cells: a novel mechanism in the pathogenesis of autoimmune arthritis. J Immunol. 2010 Jun 15;184(12):6882-90. doi: 10.4049/jimmunol.1000075. Epub 2010 May 19. — View Citation
Shi J, Knevel R, Suwannalai P, van der Linden MP, Janssen GM, van Veelen PA, Levarht NE, van der Helm-van Mil AH, Cerami A, Huizinga TW, Toes RE, Trouw LA. Autoantibodies recognizing carbamylated proteins are present in sera of patients with rheumatoid arthritis and predict joint damage. Proc Natl Acad Sci U S A. 2011 Oct 18;108(42):17372-7. doi: 10.1073/pnas.1114465108. Epub 2011 Oct 10. — View Citation
Turunen S, Koivula MK, Risteli L, Risteli J. Anticitrulline antibodies can be caused by homocitrulline-containing proteins in rabbits. Arthritis Rheum. 2010 Nov;62(11):3345-52. doi: 10.1002/art.27644. — View Citation
van Venrooij WJ, van Beers JJ, Pruijn GJ. Anti-CCP antibodies: the past, the present and the future. Nat Rev Rheumatol. 2011 Jun 7;7(7):391-8. doi: 10.1038/nrrheum.2011.76. Review. — View Citation
Wang Z, Nicholls SJ, Rodriguez ER, Kummu O, Hörkkö S, Barnard J, Reynolds WF, Topol EJ, DiDonato JA, Hazen SL. Protein carbamylation links inflammation, smoking, uremia and atherogenesis. Nat Med. 2007 Oct;13(10):1176-84. Epub 2007 Sep 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DAS28-ESR | To explore the clinical differences in activity indexes (DAS28-ESR) at 6, 12 and 18 months of follow-up according the anti-CarP status. The DAS28 is a composite score derived from 4 measures, one of them can be the erythrocyte sedimentation rate (ESR). We will be using the DAS28-ESR version. To calculate the DAS28-ESR the rheumatologist or specialist nurse will:- count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure ESR, ask participants to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28-ESR is calculated with classic calculators and resulting values are interpreted as follows: <2.6: disease remission 2.6 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity >5.1: high disease activity |
6, 12 and 18 Months |
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