Trial | NCT00902369  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    130
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
Study Started
May 31
2009
Primary Completion
Oct 31
2009
Study Completion
Jul 31
2010
Last Update
Jul 25
2016
Estimate

Drug AK106-001616

Part1: Dose escalation Part2: Dose expansion

Drug Placebo

Drug Active comparator

AK106-001616 Experimental

Placebo Placebo Comparator

Part1: AK106-001616 and Placebo

Active comparator Active Comparator

Part2: AK106-001616 and Active comparator

Criteria 

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
No Results Posted