A Phase 2, Multicenter Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197

Psoriatic Arthritis Clinical Trial

Official title:

A Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02429895
• Other study ID #: M14-198
• Secondary ID: 2014-005527-27
• Status: Terminated
• Phase: Phase 2
• First received: April 24, 2015
• Last updated: June 16, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Agency for Medicines and Medical DevicesCzech Republic: State Institute for Drug ControlLatvia: State Agency of MedicinesSpain: Agencia Española de Medicamentos y Productos SanitariosNew Zealand: MedsafeGermany: Paul-Ehrlich-InstitutItaly: The Italian Medicines AgencyFrance: Agence Nationale de Sécurité du Médicament et des produits de santéBulgaria: Bulgarian Drug AgencyPoland: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• 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:

1. Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria of Study M14-197.

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

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

• Surgically sterile (bilateral oophorectomy or hysterectomy)

If subject does not meet one of the above two categories, subject must use one of the following methods of birth control, from the time of the first dose of study drug until 150 days after the last dose of study drug:

• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation started at least 2 months prior to the first dose of study drug: oral, intravaginal or transdermal

• Progestogen-only hormonal contraception associated with inhibition of ovulation started at least two months prior to randomization: oral, injectable, or implantable

• Intrauterine device (IUD)

• Intrauterine hormone-releasing system (IUS)

• Bilateral tubal occlusion/ligation

• Be with a vasectomized partner (procedure at least 6 months earlier, the vasectomized male partner should be your sole partner)

• Sexual abstinence (refraining from heterosexual intercourse during the entire study period)

3. If male, subject must be surgically sterile (have had a vasectomy more than 6 months prior to Screening) or must be practicing at least 1 of the following methods of birth control from the time of the first dose of study drug until 150 days post last dose of study drug:

• Subject using condom and female partner(s) using an intrauterine device (IUD);

• Subject using condom and female partner(s) using hormonal contraceptives (oral, vaginal, parenteral or transdermal);

• Subject using condom and female partner(s) using double-barrier method (contraceptive sponge; diaphragm or vaginal ring with spermicidal jellies, creams, or spermicide);

• Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable.

• Subject must also agree to not donate sperm starting on the first day of study drug administration until 150 days after the last dose of study drug.

4. 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 study-specific procedures.

5. Subject is judged to be in good health as determined by the Investigator.

Exclusion Criteria:

1. Pregnant or breastfeeding or plans to become pregnant during study participation.

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

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

4. Current enrollment in another investigational study; with the exception of Study M14-197, which is required.

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• ABT-122
Injection

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 138922	Woolloongabba
Bulgaria	Site Reference ID/Investigator# 138925	Plovdiv
Bulgaria	Site Reference ID/Investigator# 138926	Plovdiv
Bulgaria	Site Reference ID/Investigator# 138927	Plovdiv
Bulgaria	Site Reference ID/Investigator# 138928	Sofia
Bulgaria	Site Reference ID/Investigator# 138929	Sofia
Bulgaria	Site Reference ID/Investigator# 138930	Sofia
Czech Republic	Site Reference ID/Investigator# 138933	Praha
Czech Republic	Site Reference ID/Investigator# 138934	Praha 4
Czech Republic	Site Reference ID/Investigator# 138932	Uherske Hradiste
Germany	Site Reference ID/Investigator# 141365	Frankfurt
Germany	Site Reference ID/Investigator# 138953	Luebeck
Hungary	Site Reference ID/Investigator# 138959	Budapest
Latvia	Site Reference ID/Investigator# 138983	Adazi
Latvia	Site Reference ID/Investigator# 138982	Riga
Latvia	Site Reference ID/Investigator# 138985	Riga
Latvia	Site Reference ID/Investigator# 138984	Valmiera
New Zealand	Site Reference ID/Investigator# 138986	Auckland
New Zealand	Site Reference ID/Investigator# 138988	Nelson
New Zealand	Site Reference ID/Investigator# 138987	Newtown, Wellington
Poland	Site Reference ID/Investigator# 139000	Bialystok
Poland	Site Reference ID/Investigator# 139012	Bydgoszcz
Poland	Site Reference ID/Investigator# 138999	Elblag
Poland	Site Reference ID/Investigator# 139007	Katowice
Poland	Site Reference ID/Investigator# 139006	Krakow
Poland	Site Reference ID/Investigator# 139005	Lublin
Poland	Site Reference ID/Investigator# 139026	Oswiecim
Poland	Site Reference ID/Investigator# 139004	Poznan
Poland	Site Reference ID/Investigator# 139001	Stalowa Wola
Poland	Site Reference ID/Investigator# 139011	Szczecin
Poland	Site Reference ID/Investigator# 139003	Torun
Poland	Site Reference ID/Investigator# 139010	Wroclaw
Romania	Site Reference ID/Investigator# 139013	Bucuresti
Romania	Site Reference ID/Investigator# 139016	Targu-Mures, Jud. Mures
Spain	Site Reference ID/Investigator# 139022	Elche
Spain	Site Reference ID/Investigator# 139020	Santiago de Compostela

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Australia,  Bulgaria,  Czech Republic,  Germany,  Hungary,  Latvia,  New Zealand,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR) 20 response rate by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24	No
Primary	American College of Rheumatology (ACR) 50 response rate by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24	No
Primary	American College of Rheumatology (ACR) 70 response rate by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24	No
Primary	Change in American College of Rheumatology (ACR) the individual component by visit	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	From Week 0 to Week 24	No
Primary	Change in Disease Activity Score DAS28 [hsCRP] by visit	Determine by disease activity score using 28 joint counts (DAS28) and high-sensitivity C-reactive protein (hsCRP) lab test.	From Week 0 to Week 24	No
Primary	Change in Psoriatic Disease Activity Score (PASDAS) by visit	PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.	From Week 0 to Week 24	No
Primary	Change in Psoriasis Area and Severity Index (PASI) by visit	Determined by scores for the amount and severity of a patient's psoriasis.	From Week 0 to Week 24	No
Primary	Change in Psoriasis Target Lesion Score by visit	Determined by plaque erythema, plaque scaling and plaque thickness scores.	From Week 0 to Week 24	No
Primary	Change in Dactylitis Assessment by visit	Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.	From Week 0 to Week 24	No
Primary	Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit	Determined by the presence and severity of enthesitis.	From Week 0 to Week 24	No
Primary	Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit	Determined by scores given by patients regarding the severity of their psoriatic symptoms.	From Week 0 to Week 24	No
Primary	Change in skin biopsy/biomarkers	Optional samples to assess changes related on disease activity/prognosis of psoriatic arthritis (PsA), autoimmunity/inflammation, and/or response to anti-PsA medications.	From Week 0 to Week 24	No
Primary	Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	From Week 0 to Week 24	No
Primary	Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	From Week 0 to Week 24	No
Primary	Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	From Week 0 to Week 24	No
Primary	Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit	Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.	From Week 0 to Week 24	No