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

NCT02429895 | Terminated Phase 2 DMC

• 2 other identifiers: M14-1982014-005527-27
• Study Type: interventional
• Target: 168
• Locations: 10 countries
• Sites: 36

Brief 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).

Conditions

Psoriatic Arthritis

Keywords

Methotrexate; Efficacy; Safety

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change in Psoriasis Target Lesion Score by visit

  Determined by plaque erythema, plaque scaling and plaque thickness scores.

  From Week 0 to Week 24

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

All subjects (open-label extension)

EXPERIMENTAL

All subjects will start treatment with ABT-122

Drug: ABT-122

Interventions

ABT-122 DRUG

Injection

All subjects (open-label extension)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or breastfeeding or plans to become pregnant during study participation.
• 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 M14-197, which is required.
• Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-122.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (36)

Site Reference ID/Investigator# 138922

Woolloongabba, 4102, Australia

Location

Site Reference ID/Investigator# 138925

Plovdiv, 4002, Bulgaria

Location

Site Reference ID/Investigator# 138926

Plovdiv, 4002, Bulgaria

Location

Site Reference ID/Investigator# 138927

Plovdiv, 4003, Bulgaria

Location

Site Reference ID/Investigator# 138928

Sofia, 1463, Bulgaria

Location

Site Reference ID/Investigator# 138930

Sofia, 1463, Bulgaria

Location

Site Reference ID/Investigator# 138929

Sofia, 1505, Bulgaria

Location

Site Reference ID/Investigator# 138934

Prague, 140 00, Czechia

Location

Site Reference ID/Investigator# 138933

Prague, 150 06, Czechia

Location

Site Reference ID/Investigator# 138932

Uherské Hradiště, 68601, Czechia

Location

Site Reference ID/Investigator# 141365

Frankfurt, 60528, Germany

Location

Site Reference ID/Investigator# 138953

Lübeck, 23538, Germany

Location

Site Reference ID/Investigator# 138959

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 138983

Ādaži, LV-2164, Latvia

Location

Site Reference ID/Investigator# 138985

Riga, LV-1012, Latvia

Location

Site Reference ID/Investigator# 138982

Riga, LV1011, Latvia

Location

Site Reference ID/Investigator# 138984

Valmiera, LV-4201, Latvia

Location

Site Reference ID/Investigator# 138986

Auckland, 2025, New Zealand

Location

Site Reference ID/Investigator# 138988

Nelson, 7010, New Zealand

Location

Site Reference ID/Investigator# 138987

Newtown, Wellington, 6021, New Zealand

Location

Site Reference ID/Investigator# 139000

Bialystok, 15-879, Poland

Location

Site Reference ID/Investigator# 139012

Bydgoszcz, 85-168, Poland

Location

Site Reference ID/Investigator# 138999

Elblag, 82-300, Poland

Location

Site Reference ID/Investigator# 139007

Katowice, 40-748, Poland

Location

Site Reference ID/Investigator# 139006

Krakow, 31-637, Poland

Location

Site Reference ID/Investigator# 139005

Lublin, 20-582, Poland

Location

Site Reference ID/Investigator# 139026

Oświęcim, 32-600, Poland

Location

Site Reference ID/Investigator# 139004

Poznan, 60-218, Poland

Location

Site Reference ID/Investigator# 139001

Stalowa Wola, 37-450, Poland

Location

Site Reference ID/Investigator# 139011

Szczecin, 70-332, Poland

Location

Site Reference ID/Investigator# 139003

Torun, 87-100, Poland

Location

Site Reference ID/Investigator# 139010

Wroclaw, 51-685, Poland

Location

Site Reference ID/Investigator# 139013

Bucharest, 011172, Romania

Location

Site Reference ID/Investigator# 139016

Targu-Mures, Jud. Mures, 540136, Romania

Location

Site Reference ID/Investigator# 139022

Elche, 03203, Spain

Location

Site Reference ID/Investigator# 139020

Santiago de Compostela, 15702, Spain

Location

Related Publications (1)

• Genovese MC, Weinblatt ME, Mease PJ, Aelion JA, Peloso PM, Chen K, Li Y, Liu J, Othman AA, Khatri A, Mansikka HT, Leszczynski P. Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis. Rheumatology (Oxford). 2018 Nov 1;57(11):1972-1981. doi: 10.1093/rheumatology/key173.

  PMID: 30032191 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

ABT-122

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Heikki T Mansikka, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

LA (4); HU (1); NZ (3); CZ (3); DE (2); AU (1); ES (2); BU (6); RO (2); PL (12)