A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients (ARABESC)

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Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: FKB327; Drug: Humira®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260791

FKB327-002

Details and patient eligibility

About

The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.

Enrollment: 728 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged 18 years or over
2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
3. Patient has active RA
4. Patient has taken a stable dose of methotrexate for at least 3 months

Exclusion criteria

1. Patient has been previously treated with adalimumab
2. Patient has been previously treated or has ongoing treatment with prohibited medications
3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks
4. Patient has positive result for HIV, HBV, HCV or TB infection

Other Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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728 participants in 2 patient groups

FKB327

Experimental group

Description:

Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.

Treatment:

Drug: FKB327

Humira®

Active Comparator group

Description:

Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.

Treatment:

Drug: Humira®