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ClinicalTrials.gov Identifier: NCT02433340

Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

    Status Active, not recruiting
    Related Conditions
    Rheumatoid Arthritis

Enrollment Details

163 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M12-965

Brief summary

Top

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963 Phase 2 RCT.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 1

0
Sherbrooke, QC
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Study Design

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

    • Subjects who have completed the preceding Study M12-963 (ABT-122) RCT study and have not developed any discontinuation criteria, as defined in Section 5.4.1 of Study M12-963.
    • If female, subject must meet one of the following criteria:
      • Postmenopausal (defined as no menses for at least 1 year).
      • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
      • Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. Females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time.
    • Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
    • Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
    • Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.

     

    • Pregnant or breastfeeding female.
    • Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
    • Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
    • Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
    • Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.

More on this trial

Clinical Trials.gov