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

EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)

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.

Study Overview

• Status: Completed
• Conditions: Palindromic Rheumatism, Wrist
• Intervention / Treatment: Drug: Abatacept Injection; Drug: hydroxycloroquina

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic I Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: abatacept; 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; Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.; Other Names: ORENCIA
Active Comparator: hydroxycloroquina; Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)	Drug: hydroxycloroquina; oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as asesed	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)	number of participants with titles positives on serum ACPA.(anti-CarP antibodies)	At any time during the follow-up (up to 24 months)

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Abatacept
• Other Study ID Numbers: PALABA 2017-004543-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No