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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01007175
• Date of registration: 02/11/2009
• Prospective Registration: No
• Primary sponsor: Ablynx
• Public title: Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: November 2009
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01007175
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Japan

Contacts

• Name: Josefin-Beate Holz
• Affiliation: Ablynx

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: ATN-103 10 mg q4wks

Biological: ATN-103 10 mg q8wks

Biological: ATN-103 80 mg q8wks

Biological: ATN-103 30 mg q4wks

Biological: ATN-103 80 mg q4wks

Primary Outcome(s)

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(s)

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

Secondary ID(s)

B2271004

3242K1-2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors