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Rheumatoid ArthritisPhase 1/2NCT01007175

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

A Phase 1/2 study testing ATN-103 10 mg q4wks, ATN-103 30 mg q4wks and ATN-103 80 mg q4wks in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
ATN-103 10 mg q4wks, ATN-103 30 mg q4wks and ATN-103 80 mg q4wks
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
15 sitesJapan
Study dates
Nov 2009to Sep 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Investigational Site

    Chiba

  • Investigational Site

    Ehime

  • Investigational Site

    Fukuoka

  • Investigational Site

    Gunma

  • Investigational Site

    Hyōgo

  • Investigational Site

    Kumamoto

  • Investigational Site

    Kyoto

  • Investigational Site

    Miyazaki

  • Investigational Site

    Nagano

  • Investigational Site

    Nagasaki

  • Investigational Site

    Osaka

  • Investigational Site

    Saga

  • Investigational Site

    Saitama

  • Investigational Site

    Tokyo

  • Investigational Site

    Toyama

Other trials in Japan

About this study

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

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.

Being tested
ATN-103 10 mg q4wks, ATN-103 30 mg q4wks, ATN-103 80 mg q4wks, ATN-103 10 mg q8wks, ATN-103 80 mg q8wks
Keywords
TNF inhibitor, Multiple ascending dose study
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATN-103 10 mg q4wksBiological

    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.

  • ATN-103 30 mg q4wksBiological

    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.

  • ATN-103 80 mg q4wksBiological

    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.

  • ATN-103 10 mg q8wksBiological

    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.

  • ATN-103 80 mg q8wksBiological

    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.

Study groups in NCT01007175
Study groupRoleWhat they receive
Cohort 1ExperimentalNot described
Receives: Biological: ATN-103 10 mg q4wks
Cohort 2ExperimentalNot described
Receives: Biological: ATN-103 30 mg q4wks
Cohort 3ExperimentalNot described
Receives: Biological: ATN-103 80 mg q4wks
Cohort 4ExperimentalNot described
Receives: Biological: ATN-103 10 mg q8wks
Cohort 5ExperimentalNot described
Receives: Biological: ATN-103 80 mg q8wks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 weeks

Secondary outcomes (1)

  1. Clinical efficacy for Rheumatoid Arthritis (RA) based on ACR responses, ACR-N, DAS 28 and EULAR response.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01007175
Sponsor's protocol ID
3242K1-2001
Other IDs
B2271004
Status last verified
Jan 2013
First submitted
2 Nov 2009
Last updated
4 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ATN-103 10 mg q4wks, ATN-103 30 mg q4wks and ATN-103 80 mg q4wks in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01007175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.

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