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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
New formulation adalimumab
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 92113
  • Site Reference ID/Investigator# 92118
  • Site Reference ID/Investigator# 92117
  • Site Reference ID/Investigator# 92115
  • Site Reference ID/Investigator# 92116
  • Site Reference ID/Investigator# 92114
  • Site Reference ID/Investigator# 92053
  • Site Reference ID/Investigator# 92054
  • Site Reference ID/Investigator# 91954
  • Site Reference ID/Investigator# 91955
  • Site Reference ID/Investigator# 91953
  • Site Reference ID/Investigator# 91956
  • Site Reference ID/Investigator# 92073
  • Site Reference ID/Investigator# 92074
  • Site Reference ID/Investigator# 92093
  • Site Reference ID/Investigator# 92095
  • Site Reference ID/Investigator# 92094
  • Site Reference ID/Investigator# 92096
  • Site Reference ID/Investigator# 92097
  • Site Reference ID/Investigator# 92098

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New formulation of adalimumab 40 mg every other week

Arm Description

New formulation adalimumab 40 mg every other week

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at 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.
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at 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))
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at 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))
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at 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 Outcome Measures

Percentage of Participants Positive for Anti-adalimumab Antibody
Percentage of participants with anti-adalimumab antibody

Full Information

First Posted
December 17, 2012
Last Updated
October 22, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01752855
Brief Title
Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
Official Title
A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New formulation of adalimumab 40 mg every other week
Arm Type
Experimental
Arm Description
New formulation adalimumab 40 mg every other week
Intervention Type
Biological
Intervention Name(s)
New formulation adalimumab
Other Intervention Name(s)
Humira
Intervention Description
New formulation adalimumab 40 mg every other week
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
Description
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.
Time Frame
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Title
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
Description
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))
Time Frame
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Title
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
Description
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))
Time Frame
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Title
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
Description
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.
Time Frame
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Secondary Outcome Measure Information:
Title
Percentage of Participants Positive for Anti-adalimumab Antibody
Description
Percentage of participants with anti-adalimumab antibody
Time Frame
Week 24 through Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Payne, PhD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 92113
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Site Reference ID/Investigator# 92118
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Site Reference ID/Investigator# 92117
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Site Reference ID/Investigator# 92115
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
Site Reference ID/Investigator# 92116
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Site Reference ID/Investigator# 92114
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Site Reference ID/Investigator# 92053
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site Reference ID/Investigator# 92054
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Site Reference ID/Investigator# 91954
City
Brno
ZIP/Postal Code
638 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 91955
City
Prague 2
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 91953
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 91956
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 92073
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Site Reference ID/Investigator# 92074
City
Vega Baja
ZIP/Postal Code
00693
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 92093
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Site Reference ID/Investigator# 92095
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Site Reference ID/Investigator# 92094
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
Facility Name
Site Reference ID/Investigator# 92096
City
Banska Bystrica
ZIP/Postal Code
97405
Country
Slovakia
Facility Name
Site Reference ID/Investigator# 92097
City
Senica
ZIP/Postal Code
905 01
Country
Slovakia
Facility Name
Site Reference ID/Investigator# 92098
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia

12. IPD Sharing Statement

Links:
URL
http://rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

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

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