Trial · NCT02486302
A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.
NCT02486302, Completed, Pfizer; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis. Trials, record NCT02486302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02486302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.
- NCT number
- NCT02486302
- Status
- Completed
- Enrollment
- 1,534 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Plaque Psoriasis
- Interventions
- Etanercept
- First posted
- 2015-07-01
- Last updated
- 2019-06-24
- Results first posted
- 2019-06-24
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | Week 12 | Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | Week 24 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | Week 12 up to Week 52 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | Week 24 up to Week 52 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | Week 12 | PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Primary | Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | Week 12 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Primary | Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | Week 12 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1. |
| Primary | Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 | Week 24 | PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Primary | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | Week 24 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Primary | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | Week 24 | DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1. |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | Week 12 | Per-protocol (PP) set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | Week 12 up to Week 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | Week 24 up to Week 52 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | Week 12 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | Week 12 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | Week 12 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | Week 24 | PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group364
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | Etanercept | 194 | Participants | ||
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | Etanercept | 203 | Participants | ||
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | Etanercept | 58 | Participants | ||
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | Etanercept | 88 | Participants | ||
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | Etanercept | 5 | Participants | ||
| Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | Etanercept | 38 | Participants | ||
| Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | Etanercept | 92 | Participants | ||
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24 | Etanercept | 11 | Participants | ||
| Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | Etanercept | 28 | Participants | ||
| Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | Etanercept | 106 | Participants |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etanercept | 1,534 | |
| Overall Study | Treated | Etanercept | 1,523 | |
| Overall Study | COMPLETED | Etanercept | 858 | |
| Overall Study | NOT COMPLETED | Etanercept | 676 |
Source ClinicalTrials.gov
Adverse events454
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 | Drug ineffective | General disorders | Etanercept | 203 | 1,465 | |
| other | Condition aggravated | General disorders | Etanercept | 35 | 1,465 | |
| other | Injection site erythema | General disorders | Etanercept | 34 | 1,465 | |
| other | Injection site reaction | General disorders | Etanercept | 22 | 1,465 | |
| other | Fatigue | General disorders | Etanercept | 13 | 1,465 | |
| other | Injection site pruritus | General disorders | Etanercept | 12 | 1,465 | |
| other | Pyrexia | General disorders | Etanercept | 10 | 1,465 | |
| other | Drug effect decreased | General disorders | Etanercept | 9 | 1,465 | |
| other | Pain | General disorders | Etanercept | 8 | 1,465 | |
| other | Injection site hypersensitivity | General disorders | Etanercept | 7 | 1,465 |
1 to 10 of 454Source ClinicalTrials.gov
See all 454 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | 5 | 1,465 |
| Total, other adverse events | Etanercept | 606 | 1,465 |
| Total, serious adverse events | Etanercept | 151 | 1,465 |
Source ClinicalTrials.gov
Papers2
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/NCT02486302
GET https://conductscience.org/api/trials/v1/NCT02486302/registered?page=2