A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients (ARABESC-OLE)

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Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Humira®; Drug: FKB327

Study type: Interventional

Funder types: Industry

Identifiers

NCT02405780

FKB327-003

Details and patient eligibility

About

The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.

Full description

The first period of this extension study was an open label, randomised, comparative, multi centre, 2 arm extension Phase 3 study in patients with RA who were taking a stable dose of MTX and who had continued from the preceding Study FKB327-002 (NCT02260791). The transition from Study FKB327-002 was ideally to occur without interruption: the Week 24 visit of Study FKB327-002 was to be on the same day as the Week 0 visit of Study FKB327-003. Patients who had received FKB327 in Study FKB327-002 received FKB327 or Humira in a 2:1 ratio and patients who had received Humira in Study FKB327-002 received Humira or FKB327 in a 2:1 ratio (Period I). The second period of the study was an open label, single arm extension in which all patients received FKB327 treatment from Week 30 to Week 76 (Period II), followed by a 4 week Follow up period.

Clinic visits were scheduled for Weeks 0, 2, 4, 8, 12, 24, 30, 32, 34, 42, 54, 66, 76, and 80. The patient or carer was allowed to administer interim doses of study drug at home every other week (eow) between clinic visits.

Enrollment: 645 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate
2. In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791)

Exclusion criteria

1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
2. Patient has presence of active and/or untreated latent tuberculosis (TB)

Other Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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645 participants in 2 patient groups

FKB327

Experimental group

Description:

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Treatment:

Drug: FKB327

Humira®

Active Comparator group

Description:

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Treatment:

Drug: Humira®