Psoriatic ArthritisPhase 2NCT02349451

A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

A Phase 2 study testing adalimumab and ABT-122 in people with Psoriatic Arthritis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment. 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?: adalimumab and ABT-122
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: No sites listed yet
Study dates: 28 Apr 2015to 4 Jul 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.
Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas other than the axilla or groin.
Have active arthritis defined by minimum disease activity criteria:
>= 3 swollen joints (based on 66 joint counts) at Screening
>= 3 tender joints (based on 68 joint counts) at Screening
On a stable dose of methotrexate (MTX) defined as:

Show all 10Show fewer

Oral or parenteral treatment >= 3 months
On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
Stable MTX dose of >= 10 mg/week and <= the upper limit of the applicable approved local label
Can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

Who cannot join

Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
Subjects on prior adalimumab may not be enrolled in the study
Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit.
Current treatment with traditional oral/intramuscular DMARDs, including conventional synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.
Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5 half-lives.
Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of the Baseline visit.

Show all 14Show fewer

Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
Laboratory values of the following at the Screening Visit:
Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females
Absolute neutrophil count (ANC) < 1500 mm^3, (or < 1200 cells/µL for subjects of African descent who are black)
Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of normal (ULN) or bilirubin >= 3 mg/dL
Serum creatinine > 1.5 x the ULN
Platelets < 100,000 cells/[mm^3] (10^9/L),
Clinically significant abnormal screening laboratory results as evaluated by the Investigator

About this study

Official title: A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate

Conditions: Psoriatic Arthritis
Being tested: adalimumab, ABT-122
Keywords: Safety, Efficacy, Methotrexate
Medical subject headings: Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

adalimumabBiological
Also called Humira, ABT-D2E7
ABT-122Biological
Also called remtolumab

Study groups in NCT02349451
Study group	Role	What they receive
Adalimumab	Active comparator	Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks Receives: Biological: adalimumab
Placebo	Placebo comparator	Double-blind placebo administered every week (EW) for 12 weeks Receives: Biological: ABT-122
ABT-122 120 mg	Experimental	Double-blind ABT-122 120 mg administered EW for 12 weeks Receives: Biological: ABT-122
ABT-122 240 mg	Experimental	Double-blind ABT-122 240 mg administered EW for 12 weeks Receives: Biological: 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 at Week 12: ABT-122 Versus Placebo
Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Measured: Week 12

Secondary outcomes (7)

ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab
Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Measured: Week 12
ACR50 Response Rate at Week 12
Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Measured: Week 12
ACR70 Response Rate at Week 12
Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Measured: Week 12
ACRn at Week 12
ACR measures percentage 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. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.
Measured: At Week 12
Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.
Measured: Baseline, Week 12
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12
PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Change From Baseline in Psoriasis Target Lesion Score at Week 12
Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 20154 Jul 2016

First posted28 Jan 2015 (estimated)
Study start28 Apr 2015
Primary completion4 Jul 2016
Study completion4 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02349451
Sponsor's protocol ID: M14-197
Other IDs: 2014-003558-15, 2014
Status last verified: Aug 2017
First submitted: 23 Jan 2015
Last updated: 4 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.
PubMed 30376130
Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579.
PubMed 29855175

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

All Psoriatic Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate
ClinicalTrials.gov ID: NCT02349451
Acronym / sponsor ID: M14-197
Conditions: Psoriatic Arthritis
Keywords: Safety, Efficacy, Methotrexate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 28 Apr 2015 (actual)
Primary completion: 4 Jul 2016 (actual)
Study completion: 4 Jul 2016 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 4 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Adalimumab	Active comparator	Biological: adalimumabDouble-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
Placebo	Placebo comparator	Biological: ABT-122Double-blind placebo administered every week (EW) for 12 weeks
ABT-122 120 mg	Experimental	Biological: ABT-122Double-blind ABT-122 120 mg administered EW for 12 weeks
ABT-122 240 mg	Experimental	Biological: ABT-122Double-blind ABT-122 240 mg administered EW for 12 weeks

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.
Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas other than the axilla or groin.
Have active arthritis defined by minimum disease activity criteria:
On a stable dose of methotrexate (MTX) defined as:

Key exclusion criteria (14 listed)

Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
Subjects on prior adalimumab may not be enrolled in the study
Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit.
Current treatment with traditional oral/intramuscular DMARDs, including conventional synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.
Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of the Baseline visit.

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
adalimumabAlso: Humira, ABT-D2E7	Biological	Adalimumab
ABT-122Also: remtolumab	Biological	ABT-122 120 mg, ABT-122 240 mg, Placebo

Primary outcome

American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo
Time frame: Week 12
Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

7 secondary outcomes

ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab
Time frame: Week 12
ACR50 Response Rate at Week 12
Time frame: Week 12
ACR70 Response Rate at Week 12
Time frame: Week 12
ACRn at Week 12
Time frame: At Week 12
Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Psoriasis Target Lesion Score at Week 12
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 4 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo EW	24	24
Adalimumab 40 mg EOW	72	71
ABT-122 120 mg EW	71	69
ABT-122 240 mg EW	73	72

Primary outcome: American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo

Time frame: Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo EW n = 24	ABT-122 120 mg EW n = 71	ABT-122 240 mg EW n = 73
Value	25.0 (11.7 to 45.2)	64.8 (53.2 to 74.9)	75.3 (64.3 to 83.9)

Placebo EW vs ABT-122 120 mg EW: response rate difference: 39.8 (95% CI 17.2 to 57.7), p <0.001, Fisher Exact
Placebo EW vs ABT-122 240 mg EW: response rate difference: 50.3 (95% CI 28.1 to 67.4), p <0.001, Fisher Exact

Population analysed: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo EW	1 of 24 (4.2%)	10 of 24 (41.7%)	Not reported
Adalimumab 40 mg EOW	0 of 72 (0%)	39 of 72 (54.2%)	Not reported
ABT-122 120 mg EW	0 of 71 (0%)	33 of 71 (46.5%)	Not reported
ABT-122 240 mg EW	1 of 73 (1.4%)	33 of 73 (45.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30376130Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.
Derived from this study: PubMed 29855175Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579.
Humira Prescribing infoLink provided by the sponsor.

Related trials for Psoriatic Arthritis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

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.

Paul Peloso, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing adalimumab and ABT-122 in people with Psoriatic Arthritis, run by AbbVie.

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 10 inclusion and 14 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: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 at Week 12: ABT-122 Versus Placebo (time frame: Week 12). 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 NCT02349451, which also lists 2 linked publications.

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 4 Aug 2017.