A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
This study has been completed.
Sponsor:
Asahi Kasei Pharma Corporation
Information provided by:
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01285752
First received: January 27, 2011
Last updated: April 6, 2012
Last verified: April 2012
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Purpose
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: AK106-001616 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, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Asahi Kasei Pharma Corporation:
| Estimated Enrollment: | 240 |
| Study Start Date: | February 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AK106-001616 |
| Experimental: 2 | Drug: AK106-001616 |
| Active Comparator: 3 | 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285752
Locations
| Czech Republic | |
| Hlucin, Czech Republic | |
| Hostivice, Czech Republic | |
| Praha, Czech Republic | |
| Uherske Hradiste, Czech Republic | |
| Zlin, Czech Republic | |
| Germany | |
| Berlin, Germany | |
| Frankfurt, Germany | |
| Hamburg, Germany | |
| Hungary | |
| Balatonfüred, Hungary | |
| Budapest, Hungary | |
| Debrecen, Hungary | |
| Poland | |
| Bialystok, Poland | |
| Elblag, Poland | |
| Lublin, Poland | |
| Poznan, Poland | |
| Warszawa, Poland | |
| Slovakia | |
| Bratislava, Slovakia | |
| Martin, Slovakia | |
| Ukraine | |
| Donetsk, Ukraine | |
| Kharkiv, Ukraine | |
| Kyiv, Ukraine | |
| Ternopil, Ukraine | |
| Vinnytsa, Ukraine | |
| Zaporizhzhia, Ukraine | |
| United Kingdom | |
| Cambridge, United Kingdom | |
| Sheffield, United Kingdom | |
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01285752 History of Changes |
| Other Study ID Numbers: | AK106 II-02 |
| Study First Received: | January 27, 2011 |
| Last Updated: | April 6, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Czech Republic: State Institute for Drug Control Poland: Ministry of Health Slovakia: State Institute for Drug Control Ukraine: Ministry of Health |
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 June 17, 2013