A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Asahi Kasei Medical

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Active comparator; Drug: AK106-001616

Study type: Interventional

Funder types: Industry

Identifiers

NCT01285752

AK106 II-02

Details and patient eligibility

About

To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA (class I to III)
• Stable dose of methotrexate (at least 12 weeks)

Exclusion criteria

• Pregnant or breastfeeding
• Abnormal screening laboratory test values considered to be clinically significant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: AK106-001616

Drug: AK106-001616

2

Experimental group

Treatment:

Drug: AK106-001616

Drug: AK106-001616

3

Active Comparator group

Treatment:

Drug: Active comparator