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

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ClinicalTrials.gov Identifier: NCT03669367
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 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)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022


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)




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)



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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.

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Responsible Party: Anna Cruceta, Project manager Clinical Trial Unit, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03669367     History of Changes
Other Study ID Numbers: PALABA 2017-004543-20
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents