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

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis 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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: New formulation adalimumab

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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 activityPatient global assessment of disease activityPatient assessment of painDisability Index of the Health AssessmentCRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))	Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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 activityPatient global assessment of disease activityPatient assessment of painDisability Index of the Health AssessmentCRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))	Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
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.	Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Positive for Anti-adalimumab Antibody	Percentage of participants with anti-adalimumab antibody	Week 24 through Week 48

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Andy Payne, PhD, AbbVie

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 22, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: M13-692; 2012-003881-42 (EudraCT Number)