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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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)
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Secondary ID [1]
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2014-005527-27
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Secondary ID [2]
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M14-198
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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American College of Rheumatology (ACR) 20 response rate by visit
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Assessment method [1]
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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.
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Timepoint [1]
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From Week 0 to Week 24
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Primary outcome [2]
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American College of Rheumatology (ACR) 50 response rate by visit
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Assessment method [2]
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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.
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Timepoint [2]
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From Week 0 to Week 24
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Primary outcome [3]
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American College of Rheumatology (ACR) 70 response rate by visit
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Assessment method [3]
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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.
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Timepoint [3]
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From Week 0 to Week 24
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Primary outcome [4]
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Change in American College of Rheumatology (ACR) the individual component by visit
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Assessment method [4]
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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.
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Timepoint [4]
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From Week 0 to Week 24
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Primary outcome [5]
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Change in Disease Activity Score DAS28 [hsCRP] by visit
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Assessment method [5]
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Determine by disease activity score using 28 joint counts (DAS28) and high-sensitivity C-reactive protein (hsCRP) lab test.
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Timepoint [5]
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From Week 0 to Week 24
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Primary outcome [6]
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Change in Psoriatic Disease Activity Score (PASDAS) by visit
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Assessment method [6]
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PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.
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Timepoint [6]
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From Week 0 to Week 24
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Primary outcome [7]
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Change in Psoriasis Area and Severity Index (PASI) by visit
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Assessment method [7]
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Determined by scores for the amount and severity of a patient's psoriasis.
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Timepoint [7]
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From Week 0 to Week 24
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Primary outcome [8]
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Change in Psoriasis Target Lesion Score by visit
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Assessment method [8]
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Determined by plaque erythema, plaque scaling and plaque thickness scores.
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Timepoint [8]
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From Week 0 to Week 24
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Primary outcome [9]
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Change in Dactylitis Assessment by visit
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Assessment method [9]
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Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.
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Timepoint [9]
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From Week 0 to Week 24
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Primary outcome [10]
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Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit
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Assessment method [10]
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Determined by the presence and severity of enthesitis.
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Timepoint [10]
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From Week 0 to Week 24
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Primary outcome [11]
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Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit
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Assessment method [11]
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Determined by scores given by patients regarding the severity of their psoriatic symptoms.
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Timepoint [11]
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From Week 0 to Week 24
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Primary outcome [12]
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Change in skin biopsy/biomarkers
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Assessment method [12]
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Optional samples to assess changes related on disease activity/prognosis of psoriatic arthritis (PsA), autoimmunity/inflammation, and/or response to anti-PsA medications.
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Timepoint [12]
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From Week 0 to Week 24
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Primary outcome [13]
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Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit
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Assessment method [13]
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Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
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Timepoint [13]
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From Week 0 to Week 24
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Primary outcome [14]
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Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit
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Assessment method [14]
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Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
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Timepoint [14]
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From Week 0 to Week 24
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Primary outcome [15]
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Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit
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Assessment method [15]
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Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
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Timepoint [15]
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From Week 0 to Week 24
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Primary outcome [16]
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Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit
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Assessment method [16]
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Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
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Timepoint [16]
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From Week 0 to Week 24
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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.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2016
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Sample size
Target
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Accrual to date
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Final
168
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Reference ID/Investigator# 138922 - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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Bulgaria
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State/province [1]
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Plovdiv
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Bulgaria
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State/province [2]
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Sofia
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Czech Republic
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State/province [3]
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Praha 4
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Country [4]
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Czech Republic
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State/province [4]
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Praha
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Country [5]
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Czech Republic
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State/province [5]
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Uherske Hradiste
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Country [6]
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Germany
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State/province [6]
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Frankfurt
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Country [7]
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Germany
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State/province [7]
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Luebeck
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Country [8]
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Hungary
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State/province [8]
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Budapest
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Latvia
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State/province [9]
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Adazi
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Latvia
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Riga
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Latvia
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State/province [11]
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Valmiera
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Country [12]
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New Zealand
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State/province [12]
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Auckland
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Country [13]
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New Zealand
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State/province [13]
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Nelson
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New Zealand
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State/province [14]
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Newtown, Wellington
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Country [15]
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Poland
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State/province [15]
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Bialystok
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Poland
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State/province [16]
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Bydgoszcz
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Poland
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State/province [17]
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Elblag
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Poland
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Katowice
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Poland
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State/province [19]
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Krakow
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Poland
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Lublin
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Poland
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Oswiecim
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Poland
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Poznan
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Poland
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State/province [23]
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Stalowa Wola
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Poland
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State/province [24]
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Szczecin
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Poland
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State/province [25]
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Torun
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Poland
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State/province [26]
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Wroclaw
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Country [27]
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Romania
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State/province [27]
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Bucuresti
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Country [28]
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Romania
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State/province [28]
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Targu-Mures, Jud. Mures
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Country [29]
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Spain
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State/province [29]
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Elche
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Country [30]
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Spain
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State/province [30]
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Santiago de Compostela
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT02429895
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Heikki T Mansikka, MD
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02429895
Download to PDF