EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT03669367
• Date of registration: 26/07/2018
• Prospective Registration: Yes
• Primary sponsor: Fundacion Clinic per a la Recerca Biomédica
• 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: June 3, 2019
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/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

Spain

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