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

This study has been completed.
Sponsor:
Information provided by:
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00902369
First received: May 14, 2009
Last updated: July 7, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AK106-001616
Drug: Placebo
Drug: Active comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Pharma Corporation:

Estimated Enrollment: 130
Study Start Date: May 2009
Arms Assigned Interventions
Experimental: AK106-001616 Drug: AK106-001616
Part1: Dose escalation Part2: Dose expansion
Placebo Comparator: Placebo
Part1: AK106-001616 and Placebo
Drug: Placebo
Active Comparator: Active comparator
Part2: AK106-001616 and Active comparator
Drug: Active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902369

Locations
Czech Republic
Hlucin, Czech Republic
Praha 2, Czech Republic
Uherske Hradiste, Czech Republic
Germany
Frankfurt, Hessen, Germany
Berlin, Germany
Hamburg, Germany
Hungary
Budapest, Hungary
Érd, Hungary
Lithuania
Vilnius, Lithuania
Romania
Bucharest, Romania
United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00902369     History of Changes
Other Study ID Numbers: AK106 II-01
Study First Received: May 14, 2009
Last Updated: July 7, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Czech Republic: State Institute for Drug Control

Keywords provided by Asahi Kasei Pharma Corporation:
AK106-001616

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014