The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669367
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Palindromic Rheumatism, Wrist Drug: Abatacept Injection Drug: hydroxycloroquina Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: National multi-center study, open, controlled and randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669367


Locations
Layout table for location information
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Anna Cruceta, Project manager Clinical Trial Unit, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03669367    
Other Study ID Numbers: PALABA 2017-004543-20
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents