Open-Label Extension Study in Rheumatoid Arthritis.

  • Research type

    Research Study

  • Full title

    Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494

  • IRAS ID

    149963

  • Contact name

    David O'Reilly

  • Contact email

    david.oreilly@wsh.nhs.uk

  • Sponsor organisation

    AbbVie Inc.

  • Eudract number

    2013-003530-33

  • Research summary

    Research Summary

    This study is an Open-Label extension study for the M13-550 and M13-537 studies. To take part in this study, participants must have completed either the M13-550 or M13-537 study, and meet the eligibility criteria specified for this study.

    This study will last approximately 100 weeks and include approximately 12 study visits to the research centre, inclusive of a Baseline/Week 0, Week 6, Week 12, Week 18 (Optional), Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, and a 30-day follow-up visit.

    Participants will be assigned to 6 mg of the study, two times a day at the first visit (Baseline/Week 0) .If participants are unable to tolerate 6 mg two times a day, they will be discontinued from the study.

    Starting at Week 6, the drug dose will be adjusted to doses of 6 mg two times a day or 12 mg two times a day based on how participants respond to treatment.

    Blood samples will be collected at various times throughout the study to measure the health of the participants, biomarkers for ABT-494 and ABT-494 drug levels.

    The purpose of this study is to determine the long term safety, tolerability, and effectiveness of study drug ABT-494 in patients with rheumatoid arthritis (RA), who have completed a preceding ABT-494 study.

    This study is being conducted at approximately at 98 research centre worldwide and up to 500 patients with RA will participate in this study.

    Summary of Results

    Rheumatoid arthritis (RA) is an autoimmune disease
    of unknown origin that causes the body’s immune system to attack itself.
    • RA targets the body’s joints, causing inflammtion (swelling, pain, and redness). These symptoms can disappear and return.
    • In this study, doctors tested a medicine called upadacitinib to treat symptoms of RA.
    • This study took place from January 2014 to July 2021 in 17 countries and included 493 patients.
    • All patients had to have completed a prior study with upadacitinib for RA before joining this study.
    • The main goal of the study was to find out if long term treatment with upadacitinib was safe and tolerable for adult patients with RA and if it improved RA symptoms.
    • Improvement in RA symptoms was based on several scoring systems. Some of these systems included questionnaires (a set of questions) completed by the patients. Other scoring systems used results of blood tests, or a combination of scores from blood tests and questionnaires.
    • This study showed that long-term treatment with upadacitinib was safe and efective at improving patients’ RA symptoms. Most patients showed improvement or maintained their level of improvement in RA symptoms from a prior upadacitinib study.
    • Around 44.4% of patients in the study had side efects. Side efects are unwanted medical events considered by the study doctors to be at least possibly related to study treatment.
    • The most common side efects in this study were increase in creatine phosphokinase in the blood (may be a sign of muscle injury and cause muscle pain), shingles (a painful rash caused by a virus), and common cold.
    • The results of this study will be used by researchers to further develop this medicine.
    • If you participated in this study and have questions about your individual care, contact the doctor or staf at your study site.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    14/LO/1604

  • Date of REC Opinion

    2 Feb 2015

  • REC opinion

    Further Information Favourable Opinion