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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01752855
First received: December 17, 2012
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: New formulation adalimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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))

  • 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 ] [ Designated as safety issue: No ]

    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))

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants Positive for Anti-adalimumab Antibody [ Time Frame: Week 24 through Week 48 ] [ Designated as safety issue: Yes ]
    Percentage of participants with anti-adalimumab antibody


Enrollment: 88
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation of adalimumab 40 mg every other week
New formulation adalimumab 40 mg every other week
Biological: New formulation adalimumab
New formulation adalimumab 40 mg every other week
Other Name: Humira

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
  2. 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.
  3. Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
  4. 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.
  5. Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

  1. 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.
  2. Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
  3. Subject plans to use any live vaccine during the study.
  4. Positive pregnancy test at Baseline (Week 0).
  5. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752855

Locations
United States, Arizona
Site Reference ID/Investigator# 92113
Mesa, Arizona, United States, 85202
United States, California
Site Reference ID/Investigator# 92118
Hemet, California, United States, 92543
United States, Kansas
Site Reference ID/Investigator# 92117
Wichita, Kansas, United States, 67203
United States, New Jersey
Site Reference ID/Investigator# 92115
Clifton, New Jersey, United States, 07012
United States, Pennsylvania
Site Reference ID/Investigator# 92116
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
Site Reference ID/Investigator# 92114
Charleston, South Carolina, United States, 29406
Belgium
Site Reference ID/Investigator# 92053
Brussels, Belgium, 1200
Site Reference ID/Investigator# 92054
Liege, Belgium, 4000
Czech Republic
Site Reference ID/Investigator# 91954
Brno, Czech Republic, 638 00
Site Reference ID/Investigator# 91955
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 91953
Uherske Hradiste, Czech Republic, 686 01
Site Reference ID/Investigator# 91956
Zlin, Czech Republic, 760 01
Germany
Site Reference ID/Investigator# 92073
Ratingen, Germany, 40882
Puerto Rico
Site Reference ID/Investigator# 92074
Vega Baja, Puerto Rico, 00693
Romania
Site Reference ID/Investigator# 92093
Bucharest, Romania, 020475
Site Reference ID/Investigator# 92095
Cluj-Napoca, Romania, 400006
Site Reference ID/Investigator# 92094
Ploiesti, Romania, 100337
Slovakia
Site Reference ID/Investigator# 92096
Banska Bystrica, Slovakia, 97405
Site Reference ID/Investigator# 92097
Senica, Slovakia, 905 01
Site Reference ID/Investigator# 92098
Zilina, Slovakia, 010 01
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Andy Payne, PhD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01752855     History of Changes
Other Study ID Numbers: M13-692, 2012-003881-42
Study First Received: December 17, 2012
Results First Received: October 22, 2014
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014