Psoriatic ArthritisPhase 2NCT02429895
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
A Phase 2 study testing ABT-122 in people with Psoriatic Arthritis, run by AbbVie at 36 sites in 10 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- ABT-122
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 36 sitesin 10 countries
- Study dates
- Oct 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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);
- 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.
- 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.
- Subject is judged to be in good health as determined by the Investigator.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
Poland12 sites
Site Reference ID/Investigator# 139000
Bialystok, 15-879
Site Reference ID/Investigator# 139012
Bydgoszcz, 85-168
Site Reference ID/Investigator# 138999
Elblag, 82-300
Site Reference ID/Investigator# 139007
Katowice, 40-748
Site Reference ID/Investigator# 139006
Krakow, 31-637
Site Reference ID/Investigator# 139005
Lublin, 20-582
Site Reference ID/Investigator# 139026
Oświęcim, 32-600
Site Reference ID/Investigator# 139004
Poznan, 60-218
Site Reference ID/Investigator# 139001
Stalowa Wola, 37-450
Site Reference ID/Investigator# 139011
Szczecin, 70-332
Site Reference ID/Investigator# 139003
Torun, 87-100
Site Reference ID/Investigator# 139010
Wroclaw, 51-685
Bulgaria6 sites
Site Reference ID/Investigator# 138925
Plovdiv, 4002
Site Reference ID/Investigator# 138926
Plovdiv, 4002
Site Reference ID/Investigator# 138927
Plovdiv, 4003
Site Reference ID/Investigator# 138928
Sofia, 1463
Site Reference ID/Investigator# 138930
Sofia, 1463
Site Reference ID/Investigator# 138929
Sofia, 1505
Latvia4 sites
Site Reference ID/Investigator# 138983
Adazi, LV-2164
Site Reference ID/Investigator# 138985
Riga, LV-1012
Site Reference ID/Investigator# 138982
Riga, LV1011
Site Reference ID/Investigator# 138984
Valmiera, LV-4201
Czechia3 sites
Site Reference ID/Investigator# 138934
Prague, 140 00
Site Reference ID/Investigator# 138933
Prague, 150 06
Site Reference ID/Investigator# 138932
Uherské Hradiště, 68601
New Zealand3 sites
Site Reference ID/Investigator# 138986
Auckland, 2025
Site Reference ID/Investigator# 138988
Nelson, 7010
Site Reference ID/Investigator# 138987
Newtown, Wellington, 6021
Germany2 sites
Site Reference ID/Investigator# 141365
Frankfurt, 60528
Site Reference ID/Investigator# 138953
Lübeck, 23538
Romania2 sites
Site Reference ID/Investigator# 139013
Bucharest, 011172
Site Reference ID/Investigator# 139016
Targu-Mures, Jud. Mures, 540136
Spain2 sites
Site Reference ID/Investigator# 139022
Elche, 03203
Site Reference ID/Investigator# 139020
Santiago de Compostela, 15702
About this study
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)
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
- Being tested
- ABT-122
- Keywords
- Methotrexate, Efficacy, Safety
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-122Drug
Injection
| Study group | Role | What they receive |
|---|---|---|
| All subjects (open-label extension) | Experimental | All subjects will start treatment with ABT-122 Receives: Drug: ABT-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Week 0 to Week 24
Change in Psoriasis Target Lesion Score by visit
Determined by plaque erythema, plaque scaling and plaque thickness scores.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Week 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Internal business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heikki T Mansikka, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429895
- Sponsor's protocol ID
- M14-198
- Other IDs
- 2014-005527-27, 2014
- Status last verified
- Jun 2016
- First submitted
- 24 Apr 2015
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30032191
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02429895
- Acronym / sponsor ID
- M14-198
- Conditions
- Psoriatic Arthritis
- Keywords
- Methotrexate, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal business decision
- Enrolment
- 168 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects (open-label extension) | Experimental | Drug: ABT-122All subjects will start treatment with ABT-122 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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:
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-122Injection | Drug | All subjects (open-label extension) |
Primary outcome
American College of Rheumatology (ACR) 20 response rate by visit
Time frame: From Week 0 to Week 24
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.
American College of Rheumatology (ACR) 50 response rate by visit
Time frame: From Week 0 to Week 24
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.
American College of Rheumatology (ACR) 70 response rate by visit
Time frame: From Week 0 to Week 24
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.
Change in American College of Rheumatology (ACR) the individual component by visit
Time frame: From Week 0 to Week 24
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.
Change in Disease Activity Score DAS28 [hsCRP] by visit
Time frame: From Week 0 to Week 24
Determine by disease activity score using 28 joint counts (DAS28) and high-sensitivity C-reactive protein (hsCRP) lab test.
Change in Psoriatic Disease Activity Score (PASDAS) by visit
Time frame: From Week 0 to Week 24
PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.
Change in Psoriasis Area and Severity Index (PASI) by visit
Time frame: From Week 0 to Week 24
Determined by scores for the amount and severity of a patient's psoriasis.
Change in Psoriasis Target Lesion Score by visit
Time frame: From Week 0 to Week 24
Determined by plaque erythema, plaque scaling and plaque thickness scores.
Change in Dactylitis Assessment by visit
Time frame: From Week 0 to Week 24
Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.
Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit
Time frame: From Week 0 to Week 24
Determined by the presence and severity of enthesitis.
Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit
Time frame: From Week 0 to Week 24
Determined by scores given by patients regarding the severity of their psoriatic symptoms.
Change in skin biopsy/biomarkers
Time frame: From Week 0 to Week 24
Optional samples to assess changes related on disease activity/prognosis of psoriatic arthritis (PsA), autoimmunity/inflammation, and/or response to anti-PsA medications.
Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit
Time frame: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit
Time frame: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit
Time frame: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit
Time frame: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Results and safety
The study was stopped early (reason given: Internal business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Derived from this study: PubMed 30032191Genovese 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki T Mansikka, MD study director
AbbVie
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-122 in people with Psoriatic Arthritis, run by AbbVie at 36 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Poland, Bulgaria, Latvia, Czechia, New Zealand and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Internal business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology (ACR) 20 response rate by visit (time frame: From Week 0 to Week 24). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.