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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Completed; Phase 4

Conditions: Palindromic Rheumatism, Wrist

Treatments: Drug: Abatacept Injection; Drug: hydroxycloroquina

Study type: Interventional

Funder types: Other

Identifiers

NCT03669367

PALABA 2017-004543-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

abatacept

Experimental group

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.

Treatment:

Drug: Abatacept Injection

hydroxycloroquina

Active Comparator group

Description:

Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)

Treatment:

Drug: hydroxycloroquina