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Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

Primary Purpose

Active Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ATN-103
ATN-103
ATN-103
ATN-103
ATN-103
Placebo
Methotrexate
Sponsored by
Ablynx, a Sanofi company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).

Exclusion Criteria:

  • Any significant health problem other than rheumatoid arthritis
  • Any clinically significant laboratory abnormalities
  • Any prior use of B cell-depleting therapy

Sites / Locations

  • Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Treatment Group 3

Treatment Group 4

Treatment Group 5

Treatment Group 6

Arm Description

ATN-103 10 mg every 4 weeks until week 12

ATN-103 10 mg every 8 weeks until week 12

ATN-103 30 mg every 4 weeks until week 12

ATN-103 80 mg every 4 weeks until week 12

ATN-103 80 mg every 8 weeks until week 12

Placebo every 4 weeks

Outcomes

Primary Outcome Measures

American College of Rheumatology (ACR) 20 response at week 16

Secondary Outcome Measures

Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments

Full Information

First Posted
August 13, 2009
Last Updated
January 28, 2013
Sponsor
Ablynx, a Sanofi company
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1. Study Identification

Unique Protocol Identification Number
NCT00959036
Brief Title
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
Official Title
A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablynx, a Sanofi company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
ATN-103 10 mg every 4 weeks until week 12
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Description
ATN-103 10 mg every 8 weeks until week 12
Arm Title
Treatment Group 3
Arm Type
Experimental
Arm Description
ATN-103 30 mg every 4 weeks until week 12
Arm Title
Treatment Group 4
Arm Type
Experimental
Arm Description
ATN-103 80 mg every 4 weeks until week 12
Arm Title
Treatment Group 5
Arm Type
Experimental
Arm Description
ATN-103 80 mg every 8 weeks until week 12
Arm Title
Treatment Group 6
Arm Type
Placebo Comparator
Arm Description
Placebo every 4 weeks
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
10 mg every 4 weeks until week 12
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
10 mg every 8 weeks until week 12
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
30 mg every 4 weeks until week 12
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
80 mg every 4 weeks until week 12
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
80 mg every 8 weeks until week 12
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20 response at week 16
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly). Exclusion Criteria: Any significant health problem other than rheumatoid arthritis Any clinically significant laboratory abnormalities Any prior use of B cell-depleting therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josefin-Beate Holz, MD
Organizational Affiliation
Ablynx, a Sanofi company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Investigational Site
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Investigational Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Investigational Site
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Investigational Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Investigational Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Investigational Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Investigational Site
City
West Yarmouth
State/Province
Massachusetts
ZIP/Postal Code
12672
Country
United States
Facility Name
Investigational Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Investigational Site
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73139
Country
United States
Facility Name
Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigational Site
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Investigational Site
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2N 7E4
Country
Canada
Facility Name
Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9L 3A2
Country
Canada
Facility Name
Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Investigational Site
City
Vogelsang
State/Province
Gommern
ZIP/Postal Code
39245
Country
Germany
Facility Name
Investigational Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Investigational Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Investigational Site
City
Kemerovo
ZIP/Postal Code
650061
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
113811
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Investigational Site
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Investigational Site
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Investigational Site
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Investigational Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Investigational Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Investigational Site
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Investigational Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Investigational Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Investigational Site
City
Berea
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Investigational Site
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Investigational Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Investigational Site
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Investigational Site
City
Chur
ZIP/Postal Code
7000
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

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