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

NCT03669367 | Completed Phase 4

• 1 other identifier: PALABA 2017-004543-20
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.

Conditions

Palindromic Rheumatism, Wrist

Outcome Measures

Primary Outcomes (1)

• The main objective of this trial is to test abatacept efficacy

  number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)

  At any time during the follow-up (up to 24 months)

Secondary Outcomes (2)

• Number of participants with treatment-related adverse events as asesed

  At any time during the follow-up (up to 24 months)

• number of participants with titles positives on serum ACPA.(anti-CarP antibodies)

  At any time during the follow-up (up to 24 months)

Study Arms (2)

abatacept

EXPERIMENTAL

abatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use.

Drug: Abatacept Injection

hydroxycloroquina

ACTIVE COMPARATOR

Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)

Drug: hydroxycloroquina

Interventions

Abatacept Injection DRUG

Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.

Also known as: ORENCIA

abatacept

hydroxycloroquina DRUG

oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)

hydroxycloroquina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Palindromic rheumatism

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager Clinical Trial Unit

Model Details: National multi-center study, open, controlled and randomized

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: September 13, 2018
• Study Start: June 3, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-07

Locations

ES (1)