search
Back to results

Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATN-103
ATN-103
Sponsored by
Ablynx, a Sanofi company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Open-label, Long-term safety study of ATN-103 in RA

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: ATN-103_30mg

Arm 2: ATN-103_80 mg

Arm Description

Outcomes

Primary Outcome Measures

Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2010
Last Updated
March 10, 2016
Sponsor
Ablynx, a Sanofi company
search

1. Study Identification

Unique Protocol Identification Number
NCT01063803
Brief Title
Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
Official Title
An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Open-label, Long-term safety study of ATN-103 in RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: ATN-103_30mg
Arm Type
Experimental
Arm Title
Arm 2: ATN-103_80 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Intervention Type
Drug
Intervention Name(s)
ATN-103
Intervention Description
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Primary Outcome Measure Information:
Title
Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.
Time Frame
18 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: Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study. Exclusion Criteria: Pregnant or nursing women. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Ablynx NV
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
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
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
Ocala
State/Province
Florida
ZIP/Postal Code
34474
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
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
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
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
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
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
75231
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
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
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
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Investigational Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site
City
Nitona-cho, Chuoh-ku, Chiba-shi
State/Province
Chiba
Country
Japan
Facility Name
Investigational Site
City
Bunkyoucho, Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Investigational Site
City
Chuoh-ku, Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational Site
City
Yoshio-machi Iizuka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational Site
City
Tohrimachi, Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Investigational Site
City
Kato
State/Province
Hyogo
Country
Japan
Facility Name
Investigational Site
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
Facility Name
Investigational Site
City
Honmachi, Higashiyama
State/Province
Kyoto
Country
Japan
Facility Name
Investigational Site
City
Miyazaki-city
State/Province
Miyazaki
Country
Japan
Facility Name
Investigational Site
City
Nagano-shi
State/Province
Nagano
Country
Japan
Facility Name
Investigational Site
City
Yamato, Sasebo
State/Province
Nagasaki
Country
Japan
Facility Name
Investigational Site
City
Higashi-tyo, Kawachi Nagano
State/Province
Osaka
Country
Japan
Facility Name
Investigational Site
City
Ureshino-machi, Ureshino-shi
State/Province
Saga
Country
Japan
Facility Name
Investigational Site
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Investigational Site
City
Midori-cho 2 chome Tokorozawa-shi
State/Province
Saitama
Country
Japan
Facility Name
Investigational Site
City
Kawada-cho, Shinjyuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Shinanomachi, Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Takaoka-shi
State/Province
Toyama
Country
Japan
Facility Name
Investigational Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Investigational Site
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Investigational Site
City
Orenburg
ZIP/Postal Code
460018
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
Les Marais
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Investigational Site
City
Berea
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Investigational Site
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site
City
Pinelands
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Investigational Site
City
Chur
ZIP/Postal Code
7000
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs