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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT00959036
First received: August 13, 2009
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Active Rheumatoid Arthritis
 Drug: ATN-103
Drug: Placebo
Drug: Methotrexate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ablynx:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) 20 response at week 16 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
 Drug: ATN-103
10 mg every 4 weeks until week 12
Drug: Methotrexate
Experimental: Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
 Drug: ATN-103
10 mg every 8 weeks until week 12
Drug: Methotrexate
Experimental: Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
 Drug: ATN-103
30 mg every 4 weeks until week 12
Drug: Methotrexate
Experimental: Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
 Drug: ATN-103
80 mg every 4 weeks until week 12
Drug: Methotrexate
Experimental: Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
 Drug: ATN-103
80 mg every 8 weeks until week 12
Drug: Methotrexate
Placebo Comparator: Treatment Group 6
Placebo every 4 weeks
 Drug: Placebo
Placebo every 4 weeks
Drug: Methotrexate

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959036

  Show 68 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz, MD Ablynx
  More Information

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT00959036     History of Changes
Other Study ID Numbers: 3242K1-2000, B2271003
Study First Received: August 13, 2009
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013