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

January 28, 2013 updated by: Ablynx

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Investigational Site
      • Leuven, Belgium, 3000
        • Investigational Site
  • Canada
      • Quebec, Canada, G1W 4R4
        • Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Investigational Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N6
        • Investigational Site
      • Ottawa, Ontario, Canada, K1H 1A2
        • Investigational Site
      • St. Catharines, Ontario, Canada, L2N 7E4
        • Investigational Site
      • Toronto, Ontario, Canada, M9L 3A2
        • Investigational Site
  • Germany
    • Gommern
      • Vogelsang, Gommern, Germany, 39245
        • Investigational Site
  • Hungary
      • Budapest, Hungary, 1027
        • Investigational Site
      • Debrecen, Hungary, 4012
        • Investigational Site
  • Russian Federation
      • Kemerovo, Russian Federation, 650061
        • Investigational Site
      • Moscow, Russian Federation, 119049
        • Investigational Site
      • Moscow, Russian Federation, 113811
        • Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Investigational Site
      • Novosibirsk, Russian Federation, 630091
        • Investigational Site
      • Orenburg, Russian Federation, 460000
        • Investigational Site
      • Petrozavodsk, Russian Federation, 185019
        • Investigational Site
      • Ryazan, Russian Federation, 390026
        • Investigational Site
      • Vladimir, Russian Federation, 600023
        • Investigational Site
      • Yaroslavl, Russian Federation, 150062
        • Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigational Site
      • Niska Banja, Serbia, 18205
        • Investigational Site
  • South Africa
      • Cape Town, South Africa, 7405
        • Investigational Site
      • Cape Town, South Africa, 7500
        • Investigational Site
      • Pretoria, South Africa, 0181
        • Investigational Site
    • KwaZulu-Natal
      • Berea, KwaZulu-Natal, South Africa, 4001
        • Investigational Site
  • Switzerland
      • Chur, Switzerland, 7000
        • Investigational Site
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Investigational Site
      • Scottsdale, Arizona, United States, 85258
        • Investigational Site
    • California
      • Riverside, California, United States, 92501
        • Investigational Site
      • Upland, California, United States, 91786
        • Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Investigational Site
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Investigational Site
      • Ocala, Florida, United States, 34474
        • Investigational Site
      • Orlando, Florida, United States, 32804
        • Investigational Site
      • Port Orange, Florida, United States, 32127
        • Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Investigational Site
    • Massachusetts
      • West Yarmouth, Massachusetts, United States, 12672
        • Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Investigational Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Investigational Site
      • Hickory, North Carolina, United States, 28601
        • Investigational Site
      • Winston Salem, North Carolina, United States, 27103
        • Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site
      • Oklahoma City, Oklahoma, United States, 73139
        • Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Investigational Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Investigational Site
      • Myrtle Beach, South Carolina, United States, 29572
        • Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Investigational Site
      • Houston, Texas, United States, 77004
        • Investigational Site
      • San Antonio, Texas, United States, 78217
        • Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
Drug: Methotrexate
Drug: ATN-103
10 mg every 4 weeks until week 12
Drug: ATN-103
10 mg every 8 weeks until week 12
Drug: ATN-103
30 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 8 weeks until week 12
EXPERIMENTAL: Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
Drug: Methotrexate
Drug: ATN-103
10 mg every 4 weeks until week 12
Drug: ATN-103
10 mg every 8 weeks until week 12
Drug: ATN-103
30 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 8 weeks until week 12
EXPERIMENTAL: Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
Drug: Methotrexate
Drug: ATN-103
10 mg every 4 weeks until week 12
Drug: ATN-103
10 mg every 8 weeks until week 12
Drug: ATN-103
30 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 8 weeks until week 12
EXPERIMENTAL: Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
Drug: Methotrexate
Drug: ATN-103
10 mg every 4 weeks until week 12
Drug: ATN-103
10 mg every 8 weeks until week 12
Drug: ATN-103
30 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 8 weeks until week 12
EXPERIMENTAL: Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
Drug: Methotrexate
Drug: ATN-103
10 mg every 4 weeks until week 12
Drug: ATN-103
10 mg every 8 weeks until week 12
Drug: ATN-103
30 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 4 weeks until week 12
Drug: ATN-103
80 mg every 8 weeks until week 12
PLACEBO_COMPARATOR: Treatment Group 6
Placebo every 4 weeks
Drug: Methotrexate
Drug: Placebo
Placebo every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American College of Rheumatology (ACR) 20 response at week 16
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablynx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (ESTIMATE)

August 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3242K1-2000
  • B2271003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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