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

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ClinicalTrials.gov Identifier: NCT01007175
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Ablynx

Brief Summary:
This primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable background of methotrexate. Some subjects will receive ATN-103 while other subjects will receive a placebo.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: ATN-103 10 mg q4wks Biological: ATN-103 30 mg q4wks Biological: ATN-103 80 mg q4wks Biological: ATN-103 10 mg q8wks Biological: ATN-103 80 mg q8wks Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ATN-103 Administered To Japanese Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 1 Biological: ATN-103 10 mg q4wks
ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
Experimental: Cohort 2 Biological: ATN-103 30 mg q4wks
ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.3 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
Experimental: Cohort 3 Biological: ATN-103 80 mg q4wks
ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
Experimental: Cohort 4 Biological: ATN-103 10 mg q8wks
ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.
Experimental: Cohort 5 Biological: ATN-103 80 mg q8wks
ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.



Primary Outcome Measures :
  1. Safety and tolerability will be evaluated on the basis of AEs, SAEs,(including injection site reactions and infections), physical examination findings, vital sign, measurements, immunogenicity assessments, early termination, and clinical laboratory test. [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Clinical efficacy for Rheumatoid Arthritis (RA) based on ACR responses, ACR-N, DAS 28 and EULAR response. [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets the ACR 1987 revised criteria for classification of Rheumatoid Arthritis (RA).
  • ACR functional class I through III.
  • Active RA at the time of screening and at baseline consisting of = 6 swollen and = 6 tender joints at least.
  • hs-CRP level = 8 mg/L.
  • Must be receiving MTX for at least 12 wks, with a stable dose and route of MTX for at least 6 wks prior to the baseline and continuing on that dose for the duration of the study.
  • The report of a chest x-ray performed within 12 wks before the screening documenting the absence of any evidence of malignancy, infection, or abnormalities suggestive of TB must be obtained and available in the subject's study file prior to baseline.
  • All WOCBP must have a negative pregnancy test result at screening and baseline.
  • All WOCBP who have sexual intercourse with a nonsurgically sterilized male partner must agree and commit to the use of the following highly effective forms of contraception for the duration of the study and for 8 wks after the last dose of investigational product.
  • All male subjects who are biologically capable of fathering children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 wks after the last dose of investigational product.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Presence of active infections or open cutaneous ulcers or any underlying disease that could predispose subjects to infections or history of serious infection within 4 wks before the baseline.
  • A history or current evidence of latent or active TB, evidence of prior or currently active TB by chest X-ray, recent close contact with an individual with active TB, or a positive Mantoux tuberculin skin test.
  • Other significant concurrent medical conditions at the time of the screening or baseline.
  • Laboratory abnormalities at screening. Positive for HBsAg, HBcAb, and/or HepCAb. ALTand/or AST= 2 times the ULN or higher. Hemoglobin = 8.5 g/dL or lower. Platelet = 125,000 /mm³ or lower, or = 1,000,000 /mm³ or higher. WBC = 3500 /mm³ or lower. Serum creatinine= 2 mg/dL or higher.
  • Any prior use of B cell-depleting therapy.
  • Receipt within 24 wks before the baseline visit:

Any cytotoxic drugs. Leflunomide. Any investigational biological drug(s).

  • Receipt within 12 wks before the baseline visit: Any biological drugs not listed under the exclusion criteria. Any surgical joint interventions (open or arthroscopic). Any investigational drugs (other than investigational biological drugs), procedures, or devices.
  • Receipt within 8 wks before the baseline: Abatacept. Any type of TNF inhibitors not listed under the exclusion criteria.
  • Receipt within 4 wks before the baseline: Any DMARDs, other than stable background MTX, or immunosuppressive drugs not listed under the exclusion criteria.
  • Etanercept. IA hyaluronic acid injections. Any live (attenuated) vaccine.
  • Receipt within 2 wks before the baseline: > 10 mg/day of oral prednisone or equivalent, or change in the dose of oral prednisone or its equivalent.
  • IA, bolus IM, or IV treatment with corticosteroids. > 1 NSAID, change of dose of the NSAID, or NSAID use greater than the maximum recommended dose.
  • Initiation of statins or dosage adjustment to a current statin. Change in the dose of folic acid.
  • Known or suspected allergy to ATN-103, any type of TNF inhibitors, human immunoglobulin proteins, or other compounds related to these classes of medication.
  • Current or history of psychiatric disease or alcohol or drug abuse that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol or give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007175


Locations
Japan
Investigational Site
Chiba, Japan
Investigational Site
Ehime, Japan
Investigational Site
Fukuoka, Japan
Investigational Site
Gunma, Japan
Investigational Site
Hyogo, Japan
Investigational Site
Kumamoto, Japan
Investigational Site
Kyoto, Japan
Investigational Site
Miyazaki, Japan
Investigational Site
Nagano, Japan
Investigational Site
Nagasaki, Japan
Investigational Site
Osaka, Japan
Investigational Site
Saga, Japan
Investigational Site
Saitama, Japan
Investigational Site
Tokyo, Japan
Investigational Site
Toyama, Japan
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz Ablynx

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01007175     History of Changes
Other Study ID Numbers: 3242K1-2001
B2271004
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: January 2013

Keywords provided by Ablynx:
TNF inhibitor
Multiple ascending dose study

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases