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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03669367
Date of registration: 26/07/2018
Prospective Registration: Yes
Primary sponsor: Fundacion Clinic per a la Recerca Biom├ędica
Public title: EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study) PALABA
Scientific title: EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
Date of first enrolment: April 1, 2019
Target sample size: 98
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03669367
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with PR according to Guerne and Weissman modified criteria (18) and with:

- Disease evolution > 3 months and < 24 months.

- ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid
factor positivity (ELISA, nephelometry or chemiluminescence).

- Greater than 18 years of age.

Exclusion Criteria:

- Persistent arthritis: (involvement in one or more joints > 1 week).

- Criteria of other rheumatic diseases (RA, SLE, etc.).

- Evidence of radiographic damage (join erosions).

- Absence of ACPA or RF.

- Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).

- Steroid treatment one month before study entry.

- Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide,
sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.

- Pregnant women or who want to be pregnant during the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Palindromic Rheumatism, Wrist
Intervention(s)
Drug: Abatacept Injection
Drug: hydroxycloroquina
Primary Outcome(s)
The main objective of this trial is to test abatacept efficacy [Time Frame: At any time during the follow-up (up to 24 months)]
Secondary Outcome(s)
number of participants with titles positives on serum ACPA.(anti-CarP antibodies) [Time Frame: At any time during the follow-up (up to 24 months)]
Number of participants with treatment-related adverse events as asesed [Time Frame: At any time during the follow-up (up to 24 months)]
Secondary ID(s)
PALABA 2017-004543-20
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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