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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Active comparator; Drug: AK106-001616

• Registration Number: NCT01285752
• Lead Sponsor: Asahi Kasei Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Study Start: 2011-02
• Primary Completion: 2012-01
• Status Verified: 2012-04
• Study Completion: 2012-12
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Active comparator	-
1	AK106-001616	-
2	AK106-001616	-