World Health Organization site
Skip Navigation Links

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.
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
Date of first enrolment: April 1, 2019
Target sample size: 98
Recruitment status: Not yet recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
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
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 available:
Date Posted:
Date Completed:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history