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

Phase 2

Completed

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

• Registration Number: NCT00902369
• Lead Sponsor: Asahi Kasei Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2009-10
• Status Verified: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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
AK106-001616	AK106-001616	-
Placebo	Placebo	Part1: AK106-001616 and Placebo
Active comparator	Active comparator	Part2: AK106-001616 and Active comparator