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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hlučín, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AK106-001616

Drug

Part1: Dose escalation Part2: Dose expansion

Placebo

Drug

Active Comparator

Drug

Sponsors and collaborators

Lead sponsor

Asahi Kasei Therapeutics Corporation

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: May 15, 2009
Registry last updated: Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed