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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02429895




Registration number
NCT02429895
Ethics application status
Date submitted
24/04/2015
Date registered
29/04/2015
Date last updated
17/06/2016

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2014-005527-27
Secondary ID [2] 0 0
M14-198
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-122

Experimental: All subjects (open-label extension) - All subjects will start treatment with ABT-122


Treatment: Drugs: ABT-122
Injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From Week 0 to Week 24
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From Week 0 to Week 24
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
From Week 0 to Week 24
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
From Week 0 to Week 24
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
From Week 0 to Week 24
Primary outcome [6] 0 0
Change in Psoriatic Disease Activity Score (PASDAS) by visit - PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.
Timepoint [6] 0 0
From Week 0 to Week 24
Primary outcome [7] 0 0
Change in Psoriasis Area and Severity Index (PASI) by visit - Determined by scores for the amount and severity of a patient's psoriasis.
Timepoint [7] 0 0
From Week 0 to Week 24
Primary outcome [8] 0 0
Change in Psoriasis Target Lesion Score by visit - Determined by plaque erythema, plaque scaling and plaque thickness scores.
Timepoint [8] 0 0
From Week 0 to Week 24
Primary outcome [9] 0 0
Change in Dactylitis Assessment by visit - Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.
Timepoint [9] 0 0
From Week 0 to Week 24
Primary outcome [10] 0 0
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.
Timepoint [10] 0 0
From Week 0 to Week 24
Primary outcome [11] 0 0
Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit - Determined by scores given by patients regarding the severity of their psoriatic symptoms.
Timepoint [11] 0 0
From Week 0 to Week 24
Primary outcome [12] 0 0
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.
Timepoint [12] 0 0
From Week 0 to Week 24
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
From Week 0 to Week 24
Primary outcome [14] 0 0
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.
Timepoint [14] 0 0
From Week 0 to Week 24
Primary outcome [15] 0 0
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.
Timepoint [15] 0 0
From Week 0 to Week 24
Primary outcome [16] 0 0
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.
Timepoint [16] 0 0
From Week 0 to Week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 138922 - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Plovdiv
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Praha 4
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Praha
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Uherske Hradiste
Country [6] 0 0
Germany
State/province [6] 0 0
Frankfurt
Country [7] 0 0
Germany
State/province [7] 0 0
Luebeck
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Latvia
State/province [9] 0 0
Adazi
Country [10] 0 0
Latvia
State/province [10] 0 0
Riga
Country [11] 0 0
Latvia
State/province [11] 0 0
Valmiera
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Nelson
Country [14] 0 0
New Zealand
State/province [14] 0 0
Newtown, Wellington
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Bydgoszcz
Country [17] 0 0
Poland
State/province [17] 0 0
Elblag
Country [18] 0 0
Poland
State/province [18] 0 0
Katowice
Country [19] 0 0
Poland
State/province [19] 0 0
Krakow
Country [20] 0 0
Poland
State/province [20] 0 0
Lublin
Country [21] 0 0
Poland
State/province [21] 0 0
Oswiecim
Country [22] 0 0
Poland
State/province [22] 0 0
Poznan
Country [23] 0 0
Poland
State/province [23] 0 0
Stalowa Wola
Country [24] 0 0
Poland
State/province [24] 0 0
Szczecin
Country [25] 0 0
Poland
State/province [25] 0 0
Torun
Country [26] 0 0
Poland
State/province [26] 0 0
Wroclaw
Country [27] 0 0
Romania
State/province [27] 0 0
Bucuresti
Country [28] 0 0
Romania
State/province [28] 0 0
Targu-Mures, Jud. Mures
Country [29] 0 0
Spain
State/province [29] 0 0
Elche
Country [30] 0 0
Spain
State/province [30] 0 0
Santiago de Compostela

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02429895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Heikki T Mansikka, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02429895