Clinical trial NCT01752855: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
timeFrame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
timeFrame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
measure: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
timeFrame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
measure: Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
timeFrame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Secondary outcomes:
measure: Percentage of Participants Positive for Anti-adalimumab Antibody
timeFrame: Week 24 through Week 48
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Site Reference ID/Investigator# 92113
state: Arizona
city: Hemet
country: United States
facility: Site Reference ID/Investigator# 92118
state: California
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 92117
state: Kansas
city: Clifton
country: United States
facility: Site Reference ID/Investigator# 92115
state: New Jersey
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 92116
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 92114
state: South Carolina
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 92053
city: Liege
country: Belgium
facility: Site Reference ID/Investigator# 92054
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 91954
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 91955
city: Uherske Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 91953
city: Zlin
country: Czech Republic
facility: Site Reference ID/Investigator# 91956
city: Ratingen
country: Germany
facility: Site Reference ID/Investigator# 92073
city: Vega Baja
country: Puerto Rico
facility: Site Reference ID/Investigator# 92074
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 92093
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 92095
city: Ploiesti
country: Romania
facility: Site Reference ID/Investigator# 92094
city: Banska Bystrica
country: Slovakia
facility: Site Reference ID/Investigator# 92096
city: Senica
country: Slovakia
facility: Site Reference ID/Investigator# 92097
city: Zilina
country: Slovakia
facility: Site Reference ID/Investigator# 92098
Study officials:
affiliation: AbbVie
name: Andy Payne, PhD
role: STUDY_DIRECTOR
References: