Trial · NCT02376790
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
NCT02376790, Phase 3, Completed, Amgen; results first posted 2019-02-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis. Trials, record NCT02376790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02376790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
- NCT number
- NCT02376790
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 851 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Psoriatic Arthritis
- Interventions
- Etanercept, Methotrexate, Placebo to Etanercept, Placebo to Methotrexate
- First posted
- 2015-03-03
- Last updated
- 2022-09-21
- Other registries' IDs
- eudract:2014-004869-24
- Results first posted
- 2019-02-22
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Baseline and week 24 | A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration. |
| Secondary | Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 | Week 24 | Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: * Tender joint count (0-68) ≤ 1 * Swollen joint count (0-66) ≤ 1 * Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3% * Patient global assessment of joint pain VAS (0-100) ≤ 15 * Patient global assessment of disease activity VAS (0-100) ≤ 20 * HAQ-DI (0-3) ≤ 0.5 * Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1 |
| Secondary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein. |
| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 50% improvement in 68 tender joint count; * ≥ 50% improvement in 66 swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein. |
| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 70% improvement in 68 tender joint count; * ≥ 70% improvement in 66 swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein. |
| Secondary | Change From Baseline in Tender Joint Count Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The tender joint count is an assessment of the pain and/or tenderness of 68 joints using a 0 to 1 point scale (0 = none, 1 = present). The total tender joint count is calculated by summing the number of joints with present tenderness. |
| Secondary | Change From Baseline in Swollen Joint Count Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The swollen joint count is an assessment of the swelling of 66 joints using a 0 to 1 point scale (0 = none, 1 = present). The total swollen joint count is calculated by summing the number of joints with present swelling. |
| Secondary | Change From Baseline in Physician Global Assessment of Disease Activity Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A global assessment of the participant's arthritis assessed by the physician on a 100 mm visual analog scale (VAS) where 0 mm = No activity at all and 100 mm = Worst activity imaginable. |
| Secondary | Change From Baseline in Patient Global Assessment of Disease Activity Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A global assessment of the participant's arthritis, assessed by the participant on a 100 mm VAS where 0 mm = No arthritis activity at all and 100 mm = Worst arthritis activity imaginable. |
| Secondary | Change From Baseline in Patient Global Assessment of Joint Pain Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A global assessment of the severity of the participant's joint pain, assessed by the participant on a 100 mm VAS where 0 mm = No pain at all and 100 mm = Worst pain imaginable. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Baseline and week 24 | All randomized participants; missing postbaseline data were imputed using non-responder imputation. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 | Week 24 | All randomized participants; missing postbaseline data were imputed using non-responder imputation. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Tender Joint Count Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point | tender joints | MEAN |
| SECONDARY | Change From Baseline in Swollen Joint Count Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point | swollen joints | MEAN |
| SECONDARY | Change From Baseline in Physician Global Assessment of Disease Activity Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point | mm | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment of Disease Activity Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point | mm | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment of Joint Pain Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | All randomized participants with non-missing data at each time point | mm | MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group468
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Methotrexate Monotherapy | 50.7 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Etanercept Monotherapy | 60.9 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Etanercept + Methotrexate | 65.0 | percentage of participants | ||
| Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 | Methotrexate Monotherapy | 22.9 | percentage of participants | ||
| Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 | Etanercept Monotherapy | 35.9 | percentage of participants | ||
| Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 | Etanercept + Methotrexate | 35.7 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Methotrexate Monotherapy | Week 4 | 25.0 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Etanercept Monotherapy | Week 4 | 44.3 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Etanercept + Methotrexate | Week 4 | 46.4 | percentage of participants | |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Methotrexate Monotherapy | Week 8 | 46.5 | percentage of participants |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methotrexate Monotherapy | 284 | |
| Overall Study | STARTED | Etanercept Monotherapy | 284 | |
| Overall Study | STARTED | Etanercept + Methotrexate | 283 | |
| Overall Study | Received Treatment | Methotrexate Monotherapy | 282 | |
| Overall Study | Received Treatment | Etanercept Monotherapy | 284 | |
| Overall Study | Received Treatment | Etanercept + Methotrexate | 282 | |
| Overall Study | COMPLETED | Methotrexate Monotherapy | 224 | |
| Overall Study | COMPLETED | Etanercept Monotherapy | 237 | |
| Overall Study | COMPLETED | Etanercept + Methotrexate | 230 | |
| Overall Study | NOT COMPLETED | Methotrexate Monotherapy | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,593
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 | Anaemia | Blood and lymphatic system disorders | Methotrexate Monotherapy | 4 | 282 | |
| other | Anaemia | Blood and lymphatic system disorders | Etanercept Monotherapy | 1 | 282 | |
| other | Anaemia | Blood and lymphatic system disorders | Etanercept + Methotrexate | 2 | 284 | |
| other | Leukopenia | Blood and lymphatic system disorders | Methotrexate Monotherapy | 1 | 282 | |
| other | Leukopenia | Blood and lymphatic system disorders | Etanercept Monotherapy | 1 | 282 | |
| other | Leukopenia | Blood and lymphatic system disorders | Etanercept + Methotrexate | 2 | 284 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Methotrexate Monotherapy | 1 | 282 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Etanercept Monotherapy | 0 | 282 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Etanercept + Methotrexate | 0 | 284 | |
| other | Neutropenia | Blood and lymphatic system disorders | Methotrexate Monotherapy | 0 | 282 |
1 to 10 of 1,593Source ClinicalTrials.gov
See all 1,593 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate Monotherapy | 0 | 282 |
| Total, all-cause mortality | Etanercept Monotherapy | 0 | 282 |
| Total, all-cause mortality | Etanercept + Methotrexate | 0 | 284 |
| Total, other adverse events | Methotrexate Monotherapy | 210 | 282 |
| Total, other adverse events | Etanercept Monotherapy | 185 | 282 |
| Total, other adverse events | Etanercept + Methotrexate | 214 | 284 |
| Total, serious adverse events | Methotrexate Monotherapy | 16 | 282 |
| Total, serious adverse events | Etanercept Monotherapy | 19 | 282 |
| Total, serious adverse events | Etanercept + Methotrexate | 17 | 284 |
Source ClinicalTrials.gov
Papers5
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02376790
GET https://conductscience.org/api/trials/v1/NCT02376790/registered?page=2