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

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752855
• Other study ID #: M13-692
• Secondary ID: 2012-003881-42
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2012
• Last updated: October 22, 2014
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• New formulation adalimumab
New formulation adalimumab 40 mg every other week

Locations

Country	Name	City	State
Belgium	Site Reference ID/Investigator# 92053	Brussels
Belgium	Site Reference ID/Investigator# 92054	Liege
Czech Republic	Site Reference ID/Investigator# 91954	Brno
Czech Republic	Site Reference ID/Investigator# 91955	Prague 2
Czech Republic	Site Reference ID/Investigator# 91953	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 91956	Zlin
Germany	Site Reference ID/Investigator# 92073	Ratingen
Puerto Rico	Site Reference ID/Investigator# 92074	Vega Baja
Romania	Site Reference ID/Investigator# 92093	Bucharest
Romania	Site Reference ID/Investigator# 92095	Cluj-Napoca
Romania	Site Reference ID/Investigator# 92094	Ploiesti
Slovakia	Site Reference ID/Investigator# 92096	Banska Bystrica
Slovakia	Site Reference ID/Investigator# 92097	Senica
Slovakia	Site Reference ID/Investigator# 92098	Zilina
United States	Site Reference ID/Investigator# 92114	Charleston	South Carolina
United States	Site Reference ID/Investigator# 92115	Clifton	New Jersey
United States	Site Reference ID/Investigator# 92118	Hemet	California
United States	Site Reference ID/Investigator# 92113	Mesa	Arizona
United States	Site Reference ID/Investigator# 92116	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 92117	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Germany,  Puerto Rico,  Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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))	Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48	No
Primary	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))	Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48	No
Primary	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	No
Secondary	Percentage of Participants Positive for Anti-adalimumab Antibody	Percentage of participants with anti-adalimumab antibody	Week 24 through Week 48	Yes

External Links

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