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

AbbVie (prior sponsor, Abbott)88 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

New formulation adalimumabBIOLOGICAL

New formulation adalimumab 40 mg every other week

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Site Reference ID/Investigator# 92113

Mesa, Arizona, United States

Site Reference ID/Investigator# 92118

Outcomes

Primary Outcomes

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.

Time frame: 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 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

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))

Time frame: 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

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (20)

Outcomes

Primary Outcomes

Secondary Outcomes