EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study) (PALABA)
Primary Purpose
Palindromic Rheumatism, Wrist
Status
Active
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Abatacept Injection
hydroxycloroquina
Sponsored by
About this trial
This is an interventional treatment trial for Palindromic Rheumatism, Wrist
Eligibility 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.
Sites / Locations
- Hospital Clinic i Provincial de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
abatacept
hydroxycloroquina
Arm Description
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.
Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Number of participants with treatment-related adverse events as asesed
Number of participants with treatment-related adverse events as asesed
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
Full Information
NCT ID
NCT03669367
First Posted
July 26, 2018
Last Updated
July 14, 2023
Sponsor
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT03669367
Brief Title
EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
Acronym
PALABA
Official Title
EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palindromic Rheumatism, Wrist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
National multi-center study, open, controlled and randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abatacept
Arm Type
Experimental
Arm Description
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.
Arm Title
hydroxycloroquina
Arm Type
Active Comparator
Arm Description
Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)
Intervention Type
Drug
Intervention Name(s)
Abatacept Injection
Other Intervention Name(s)
ORENCIA
Intervention Description
Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.
Intervention Type
Drug
Intervention Name(s)
hydroxycloroquina
Intervention Description
oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)
Primary Outcome Measure Information:
Title
The main objective of this trial is to test abatacept efficacy
Description
number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)
Time Frame
At any time during the follow-up (up to 24 months)
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as asesed
Description
Number of participants with treatment-related adverse events as asesed
Time Frame
At any time during the follow-up (up to 24 months)
Title
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
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