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

Palindromic Rheumatism, Wrist Clinical Trial

— PALABA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03669367
• Other study ID #: PALABA 2017-004543-20
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 3, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Palindromic Rheumatism, Wrist
• Rheumatic Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)