A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
1 other identifier
interventional
240
7 countries
26
Brief Summary
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Feb 2011
Typical duration for phase_2 rheumatoid-arthritis
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2011
CompletedFirst Posted
Study publicly available on registry
January 28, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 25, 2016
April 1, 2012
11 months
January 27, 2011
July 21, 2016
Conditions
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of RA (class I to III)
- Stable dose of methotrexate (at least 12 weeks)
You may not qualify if:
- Pregnant or breastfeeding
- Abnormal screening laboratory test values considered to be clinically significant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Hlučín, Czechia
Unknown Facility
Hostivice, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Uherské Hradiště, Czechia
Unknown Facility
Zlín, Czechia
Unknown Facility
Berlin, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Balatonfüred, Hungary
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
Unknown Facility
Bialystok, Poland
Unknown Facility
Elblag, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Bratislava, Slovakia
Unknown Facility
Martin, Slovakia
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Ternopil, Ukraine
Unknown Facility
Vinnytsa, Ukraine
Unknown Facility
Zaporizhzhia, Ukraine
Unknown Facility
Cambridge, United Kingdom
Unknown Facility
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2011
First Posted
January 28, 2011
Study Start
February 1, 2011
Primary Completion
January 1, 2012
Study Completion
December 1, 2012
Last Updated
July 25, 2016
Record last verified: 2012-04