Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

Rheumatoid Arthritis Clinical Trial

Official title:

Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433340
• Other study ID #: M12-965
• Secondary ID: 2014-001471-31
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2015
• Last updated: May 31, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyNew Zealand: MedsafePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Paul-Ehrlich-InstitutTurkey: Ministry of HealthHungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlRomania: National Agency for Medicines and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963 Phase 2 RCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subjects who have completed the preceding Study M12-963 (ABT-122) RCT study and have not developed any discontinuation criteria, as defined in Section 5.4.1 of Study M12-963.

• If female, subject must meet one of the following criteria:

1. Postmenopausal (defined as no menses for at least 1 year).

2. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).

3. Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. Females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time.

• Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.

• Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

• Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.

Exclusion Criteria:

• Pregnant or breastfeeding female.

• Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.

• Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.

• Current enrollment in another investigational study; with the exception of Study M12-963, which is required.

• Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ABT-122
Injection

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 135738	Plovdiv
Bulgaria	Site Reference ID/Investigator# 135739	Sofia
Bulgaria	Site Reference ID/Investigator# 137989	Sofia
Czech Republic	Site Reference ID/Investigator# 135753	Ostrava-Trebovice
Czech Republic	Site Reference ID/Investigator# 135755	Praha
Czech Republic	Site Reference ID/Investigator# 135754	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 137178	Zlin
Germany	Site Reference ID/Investigator# 135766	Erfurt
Hungary	Site Reference ID/Investigator# 135779	Budapest
Hungary	Site Reference ID/Investigator# 135782	Kiskunhalas
Hungary	Site Reference ID/Investigator# 135783	Kistarcsa
Hungary	Site Reference ID/Investigator# 135781	Szolnok
New Zealand	Site Reference ID/Investigator# 135784	Auckland
New Zealand	Site Reference ID/Investigator# 135785	Nelson
Poland	Site Reference ID/Investigator# 135788	Bialystok
Poland	Site Reference ID/Investigator# 137179	Bochnia
Poland	Site Reference ID/Investigator# 135786	Elblag
Poland	Site Reference ID/Investigator# 135790	Grodzisk Mazowieckie
Poland	Site Reference ID/Investigator# 135797	Katowice
Poland	Site Reference ID/Investigator# 135793	Oswiecim
Poland	Site Reference ID/Investigator# 135792	Poznan
Poland	Site Reference ID/Investigator# 135789	Stalowa Wola
Poland	Site Reference ID/Investigator# 135791	Torun
Poland	Site Reference ID/Investigator# 135796	Warszawa
Poland	Site Reference ID/Investigator# 135798	Wroclaw
Poland	Site Reference ID/Investigator# 136880	Wroclaw
Romania	Site Reference ID/Investigator# 135801	Bucharest
Romania	Site Reference ID/Investigator# 135804	Bucharest
Romania	Site Reference ID/Investigator# 135805	Oradea
Romania	Site Reference ID/Investigator# 135803	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Germany,  Hungary,  New Zealand,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in American College of Rheumatology (ACR) 20 Response Rate	ACR criteria measures improvement in tender or swollen joint counts	Up to Week 24	No
Primary	Change in ACR 50 Response Rate	ACR criteria measures improvement in tender or swollen joint counts.	Up to Week 24	No
Primary	Change in ACR 70 Response Rate	ACR criteria measures improvement in tender or swollen joint counts.	Up to Week 24	No
Primary	Change in Patient's Assessment of Pain	Determined by Joint Evaluation, Visual Analog Scale (VAS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT), Rheumatoid Arthritis Work Instability Scale (RA-WIS), Short Form Health Survey (SF-36)	From Week 0 to Week 24	No
Primary	Change in Patient's Global Assessment of Disease Activity	Determined by VAS	From Week 0 to Week 24	No
Primary	Change in Health Assessment Questionnaire Disability Index	Determined by the Health Assessment Questionnaire (HAQ-DI)	From Week 0 to Week 24	No
Primary	Change in High-Sensitivity C-Reactive Protein (hsCRP)	Determined by hsCRP lab test	From Week 0 to Week 24	No
Primary	Proportion of subjects achieving Low Disease Activity (LDA) per DAS 28	Determine by disease activity score using 28 joint counts (DAS 28) [CRP].	Up to Week 24	No
Primary	Proportion of subjects achieving Clinical Remission	Determine by DAS [CRP] and CDAI criteria	Up to Week 24	No
Primary	Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale	Using the FACIT Fatigue Scale	From Week 0 to Week 24	No
Primary	Change in Work Instability Scale - Rheumatoid Arthritis (RA-WIS)	Using RA-WIS Scale	From Week 0 to Week 24	No
Primary	Change in Short Form Health Survey 36 (SF-36)	Using the SF-36 questionnaire	From Week 0 to Week 24	No
Primary	Incidence of Adverse Events	Analysis of adverse events, serious adverse events, and premature discontinuation	Up to 70 day follow-up visit (70 days after last dose of study drug)	Yes
Primary	Change in Physical Examination	A symptom-directed physical exam will be performed when necessary, as per Investigator's judgement.	From Week 0 through 70 day follow-up visit (70 days after the last dose of study drug)	Yes
Primary	Proportion of subjects achieving low disease activity (LDA) per CDAI criteria	Determined by clinical disease activity index (CDAI) criteria	Up to Week 24	No