Psoriatic ArthritisPhase 2NCT01516957

AMG 827 in Subjects With Psoriatic Arthritis

A Phase 2 study testing AMG 827 140, AMG 827 280 and AMG 827 210 in people with Psoriatic Arthritis, run by Bausch Health Americas, Inc. at 31 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriatic Arthritis
What is being tested?: AMG 827 140, AMG 827 280 and AMG 827 210
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 168 participants
Where: 31 sitesin 2 countries
Study dates: Oct 2011to Sep 2015
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months
Subject has ≥ 3 tender and ≥ 3 swollen joints

Who cannot join

Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)
Significant concurrent medical conditions
Pregnant or breast feeding
Significant Laboratory abnormalities
Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days
Use of anti-TNF therapy within 2 months

Show all 9Show fewer

Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months
Prior use of rituximab
Prior use of anti-IL-17 biologic therapy, including AMG 827

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States22 sites

Research Site
Baton Rouge, Louisiana, 70809
Research Site
Boise, Idaho, 83702
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Frederick, Maryland, 21702
Research Site
Grand Rapids, Michigan, 49546
Research Site
Hemet, California, 92543
Research Site
Huntington Beach, California, 92646
Research Site
La Jolla, California, 92037
Research Site
Lansing, Michigan, 48910
Research Site
Lebanon, New Hampshire, 03756
Research Site
Lexington, Kentucky, 40504
Research Site
Los Angeles, California, 90095
Research Site
Palm Desert, California, 92260
Research Site
Palo Alto, California, 94304
Research Site
Peoria, Arizona, 85381
Research Site
Portland, Oregon, 97239
Research Site
Rochester, New York, 14642
Research Site
Sarasota, Florida, 34239
Research Site
Scottsdale, Arizona, 85258
Research Site
Seattle, Washington, 98122
Research Site
Tucson, Arizona, 85711
Research Site
Victorville, California, 92395

Other trials in United States

Canada9 sites

Research Site
Newmarket, Ontario, L3Y 3R7
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1V 3M7
Research Site
Québec, G1W 4R4
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8
Research Site
Trois-Rivières, Quebec, G8Z 1Y2
Research Site
Victoria, British Columbia, V8P 5P6
Research Site
Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis.

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Read the detailed description

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Conditions: Psoriatic Arthritis
Being tested: AMG 827 140, Placebo, AMG 827 280, AMG 827 210
Keywords: Psoriatic Arthritis, IL-17, AMG 827, AMG827, Musculoskeletal Disease, Spondylarthropathy
Medical subject headings: Arthritis, Psoriatic, Musculoskeletal Diseases, Spondylarthropathies

What participants receive

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

AMG 827 140Drug
140 mg AMG 827 SC (subcutaneous)
PlaceboDrug
Placebo SC (subcutaneous)
AMG 827 280Drug
280 mg AMG 827 SC (subcutaneous)
AMG 827 210Drug
210 mg AMG 827 SC (subcutaneous)

Study groups in NCT01516957
Study group	Role	What they receive
AMG 827 140	Experimental	140 mg AMG 827 Receives: Drug: AMG 827 140
Placebo SC	Placebo comparator	Placebo Receives: Drug: Placebo
AMG 827 280	Experimental	280 mg AMG 827 Receives: Drug: AMG 827 280
AMG 827 210	Experimental	AMG 827 SC 210 mg Receives: Drug: AMG 827 210

What is being measured

The primary outcome is the main question the study is designed to answer.

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20%
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12. ACR20 responders are subjects with 20% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Measured: Baseline to week 12

Secondary outcomes (4)

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 50 response at week 12. ACR50 responders are subjects with 50% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Measured: Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 70 response at Week 12. ACR70 responders are subjects with 70% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Measured: Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI)
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12.
CDAI = SJC(28) + TJC(28) + PGA + EGA
- SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees)
- TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees)
- PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) A CDAI reduction of 6.5 represents moderate improvement.
- EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)
Measured: Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Disease Activity Score With a 28 Joint Count (DAS 28)
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Disease Activity Score with a 28 joint count (DAS 28) change from baseline at week 12.
The DAS28 is a composite score derived from 4 measures. To calculate the DAS28:
1. count the number of swollen joints (out of the 28),
2. count the number of tender joints (out of the 28),
3. take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP),
4. ask the participant to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad).
These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Measured: Baseline to week 12

Timeline

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

Oct 2011Sep 2015

First posted25 Jan 2012 (estimated)
Study startOct 2011
Primary completionSep 2012
Study completionSep 2015

Why it stopped: Sponsor decision

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 Bausch Health Americas, Inc.The 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01516957
Sponsor's protocol ID: 20101227
Status last verified: Aug 2020
First submitted: 18 Aug 2011
Last updated: 27 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Publications

Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231.
PubMed 24918373
Mease PJ, Genovese MC, Mutebi A, Viswanathan HN, Chau D, Feng J, Erondu N, Nirula A. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis. J Rheumatol. 2016 Feb;43(2):343-9. doi: 10.3899/jrheum.150182. Epub 2016 Jan 15.
PubMed 26773108

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?

See locations

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 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis.
ClinicalTrials.gov ID: NCT01516957
Acronym / sponsor ID: 20101227
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis, IL-17, AMG 827, AMG827, Musculoskeletal Disease, Spondylarthropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 168 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2015 (actual)
First posted: 25 Jan 2012 (estimated)
Results: Posted 27 Aug 2020

Clinical summary

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

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Detailed description

Study design

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

Arm	Type	Receives
AMG 827 140	Experimental	Drug: AMG 827 140140 mg AMG 827
Placebo SC	Placebo comparator	Drug: PlaceboPlacebo
AMG 827 280	Experimental	Drug: AMG 827 280280 mg AMG 827
AMG 827 210	Experimental	Drug: AMG 827 210AMG 827 SC 210 mg

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months
Subject has ≥ 3 tender and ≥ 3 swollen joints

Key exclusion criteria (9 listed)

Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)
Significant concurrent medical conditions
Pregnant or breast feeding
Significant Laboratory abnormalities
Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days

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
AMG 827 140140 mg AMG 827 SC (subcutaneous)	Drug	AMG 827 140
PlaceboPlacebo SC (subcutaneous)	Drug	Placebo SC
AMG 827 280280 mg AMG 827 SC (subcutaneous)	Drug	AMG 827 280
AMG 827 210210 mg AMG 827 SC (subcutaneous)	Drug	AMG 827 210

Primary outcome

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20%
Time frame: Baseline to week 12
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12. ACR20 responders are subjects with 20% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.

4 secondary outcomes

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50
Time frame: Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70
Time frame: Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI)
Time frame: Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Disease Activity Score With a 28 Joint Count (DAS 28)
Time frame: Baseline to week 12

Results and safety

Results posted to the registry on 27 Aug 2020, 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 SC	55	52
140mg SC	57	53
280mg SC	56	51
Open Label AMG 827 SC 210 or 280 mg	0	0

Primary outcome: To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20%

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

Measure	Placebo SC n = 52	AMG 827 140 n = 53	AMG 827 280 n = 50
Value	19.2 (9.6 to 32.5)	39.6 (26.5 to 54)	44 (30 to 58.7)

Population analysed: Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC	13 of 52 (25%)	52 of 52 (100%)	Not reported
AMG 827 140	15 of 53 (28.3%)	50 of 53 (94.3%)	Not reported
AMG 827 280	18 of 51 (35.3%)	50 of 51 (98%)	Not reported
Open Label 210 mg or 280 mg AMG 827	31 of 156 (19.9%)	153 of 156 (98.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24918373Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231.
Derived from this study: PubMed 26773108Mease PJ, Genovese MC, Mutebi A, Viswanathan HN, Chau D, Feng J, Erondu N, Nirula A. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis. J Rheumatol. 2016 Feb;43(2):343-9. doi: 10.3899/jrheum.150182. Epub 2016 Jan 15.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes

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.

MD study director

Amgen

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 827 140, AMG 827 280 and AMG 827 210 in people with Psoriatic Arthritis, run by Bausch Health Americas, Inc. at 31 sites in 2 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 2 inclusion and 9 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada. 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. 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 27 Aug 2020). 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?

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20% (time frame: Baseline to 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 NCT01516957, 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 27 Aug 2020.