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; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902369

AK106 II-01

Details and patient eligibility

About

This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study

Enrollment: 130 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: Quadruple Blind

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130 participants in 3 patient groups, including a placebo group

AK106-001616

Experimental group

Treatment:

Drug: AK106-001616

Placebo

Placebo Comparator group

Description:

Part1: AK106-001616 and Placebo

Treatment:

Drug: Placebo

Active comparator

Active Comparator group

Description:

Part2: AK106-001616 and Active comparator

Treatment:

Drug: Active comparator