EFFECTS OF ABATACEPT on the Progression… | Clinical Trial

Key information

Conditions

Palindromic Rheumatism, Wrist Palindromic rheumatism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ORENCIA

hydroxycloroquina

Drug

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

Primary outcomes

The main objective of this trial is to test abatacept efficacy

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

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

Secondary outcomes

Number of participants with treatment-related adverse events as asesed

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

Number of participants with treatment-related adverse events as asesed
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 titles positives on serum ACPA.(anti-CarP antibodies)

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: PALABA

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2024
First posted: Sep 13, 2018
Registry last updated: Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.