Trial · NCT01516957
AMG 827 in Subjects With Psoriatic Arthritis
NCT01516957, Phase 2, Terminated, Bausch Health Americas, Inc.; results first posted 2020-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AMG 827 in Subjects With Psoriatic Arthritis. Trials, record NCT01516957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01516957
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMG 827 in Subjects With Psoriatic Arthritis
- NCT number
- NCT01516957
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 168 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Psoriatic Arthritis
- Interventions
- AMG 827 140, Placebo, AMG 827 280, AMG 827 210
- First posted
- 2012-01-25
- Last updated
- 2020-08-27
- Results first posted
- 2020-08-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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% | 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. |
| Secondary | To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 | Baseline to week 12 | 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. |
| Secondary | To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 | 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 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. |
| Secondary | To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI) | Baseline to week 12 | 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) |
| Secondary | 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) | Baseline to week 12 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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% | Baseline to week 12 | Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit | percentage of participants | NUMBER |
| SECONDARY | To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 | Baseline to week 12 | Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit | percentage of participants | NUMBER |
| SECONDARY | To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 | Baseline to week 12 | Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit | percentage of participants | NUMBER |
| SECONDARY | To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI) | Baseline to week 12 | Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit | score on a scale | MEAN |
| SECONDARY | 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) | Baseline to week 12 | Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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% | Placebo SC | 19.2 | 95% Confidence Interval 9.6 to 32.5 | percentage of participants | |
| 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% | AMG 827 140 | 39.6 | 95% Confidence Interval 26.5 to 54 | percentage of participants | |
| 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% | AMG 827 280 | 44 | 95% Confidence Interval 30 to 58.7 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 | Placebo SC | 3.8 | 95% Confidence Interval 0.5 to 13.2 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 | AMG 827 140 | 15.1 | 95% Confidence Interval 6.7 to 27.6 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 | AMG 827 280 | 15.7 | 95% Confidence Interval 7.0 to 28.6 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 | Placebo SC | 0 | 95% Confidence Interval 0 to 6.7 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 | AMG 827 140 | 5.7 | 95% Confidence Interval 1.2 to 15.7 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 | AMG 827 280 | 5.9 | 95% Confidence Interval 1.2 to 16.2 | percentage of participants | |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI) | Placebo SC | -3.96 | Standard Deviation 10.32 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled Phase | STARTED | Placebo SC | 55 | |
| Placebo-controlled Phase | STARTED | 140mg SC | 57 | |
| Placebo-controlled Phase | STARTED | 280mg SC | 56 | |
| Placebo-controlled Phase | STARTED | Open Label AMG 827 SC 210 or 280 mg | 0 | |
| Placebo-controlled Phase | COMPLETED | Placebo SC | 52 | |
| Placebo-controlled Phase | COMPLETED | 140mg SC | 53 | |
| Placebo-controlled Phase | COMPLETED | 280mg SC | 51 | |
| Placebo-controlled Phase | COMPLETED | Open Label AMG 827 SC 210 or 280 mg | 0 | |
| Placebo-controlled Phase | NOT COMPLETED | Placebo SC | 3 | |
| Placebo-controlled Phase | NOT COMPLETED | 140mg SC | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory Tract Infection | Infections and infestations | Placebo SC | 8 | 52 | |
| other | Upper respiratory Tract Infection | Infections and infestations | AMG 827 140 | 14 | 53 | |
| other | Upper respiratory Tract Infection | Infections and infestations | AMG 827 280 | 11 | 51 | |
| other | Upper respiratory Tract Infection | Infections and infestations | Open Label 210 mg or 280 mg AMG 827 | 33 | 156 | |
| other | Nasopharyngitis | Investigations | Placebo SC | 9 | 52 | |
| other | Nasopharyngitis | Investigations | AMG 827 140 | 10 | 53 | |
| other | Nasopharyngitis | Investigations | AMG 827 280 | 10 | 51 | |
| other | Nasopharyngitis | Investigations | Open Label 210 mg or 280 mg AMG 827 | 29 | 156 | |
| other | urinary tract infection | Infections and infestations | Placebo SC | 5 | 52 | |
| other | urinary tract infection | Infections and infestations | AMG 827 140 | 10 | 53 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo SC | ||
| Total, all-cause mortality | AMG 827 140 | ||
| Total, all-cause mortality | AMG 827 280 | ||
| Total, all-cause mortality | Open Label 210 mg or 280 mg AMG 827 | ||
| Total, other adverse events | Placebo SC | 52 | 52 |
| Total, other adverse events | AMG 827 140 | 50 | 53 |
| Total, other adverse events | AMG 827 280 | 50 | 51 |
| Total, other adverse events | Open Label 210 mg or 280 mg AMG 827 | 153 | 156 |
| Total, serious adverse events | Placebo SC | 13 | 52 |
| Total, serious adverse events | AMG 827 140 | 15 | 53 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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