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Completed

NCT Number: NCT01752855

Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 92053, Brussels, Belgium

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About this study

All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
  • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
  • Hormonal contraceptives for 90 days prior to study drug administration;
  • A vasectomized partner.
  • Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
  • Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
  • Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

Exclusion criteria

  • Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  • Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
  • Subject plans to use any live vaccine during the study.
  • Positive pregnancy test at Baseline (Week 0).
  • Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Treatment and study plan

New formulation adalimumab

Biological

New formulation adalimumab 40 mg every other week

Other names: Humira

Primary outcomes

  1. Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48

    Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

    The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

  2. Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48

    Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

    American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

    • ≥ 20% improvement in tender joint count;
    • ≥ 20% improvement in swollen joint count; and
    • ≥ 20% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))

  3. Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48

    Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

    American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

    • ≥ 50% improvement in tender joint count;
    • ≥ 50% improvement in swollen joint count; and
    • ≥ 50% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))

  4. Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48

    Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.

Secondary outcomes

  1. Percentage of Participants Positive for Anti-adalimumab Antibody

    Time frame: Week 24 through Week 48

    Percentage of participants with anti-adalimumab antibody

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2012
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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