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

NCT ID: NCT01285752

Last Updated: 2016-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-12-31

Brief Summary

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To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AK106-001616

Intervention Type DRUG

2

Group Type EXPERIMENTAL

AK106-001616

Intervention Type DRUG

3

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type DRUG

Interventions

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AK106-001616

Intervention Type DRUG

AK106-001616

Intervention Type DRUG

Active comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asahi Kasei Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hlučín, , Czechia

Site Status

Hostivice, , Czechia

Site Status

Prague, , Czechia

Site Status

Uherské Hradiště, , Czechia

Site Status

Zlín, , Czechia

Site Status

Berlin, , Germany

Site Status

Frankfurt, , Germany

Site Status

Hamburg, , Germany

Site Status

Balatonfüred, , Hungary

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Bialystok, , Poland

Site Status

Elblag, , Poland

Site Status

Lublin, , Poland

Site Status

Poznan, , Poland

Site Status

Warsaw, , Poland

Site Status

Bratislava, , Slovakia

Site Status

Martin, , Slovakia

Site Status

Donetsk, , Ukraine

Site Status

Kharkiv, , Ukraine

Site Status

Kyiv, , Ukraine

Site Status

Ternopil, , Ukraine

Site Status

Vinnytsa, , Ukraine

Site Status

Zaporizhzhia, , Ukraine

Site Status

Cambridge, , United Kingdom

Site Status

Sheffield, , United Kingdom

Site Status

Countries

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Czechia Germany Hungary Poland Slovakia Ukraine United Kingdom

Other Identifiers

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AK106 II-02

Identifier Type: -

Identifier Source: org_study_id

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