Trial · NCT01623752
Prospective Evaluation of the Radiographic Efficacy of Enbrel
NCT01623752, Completed, Pfizer; results first posted 2019-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prospective Evaluation of the Radiographic Efficacy of Enbrel. Trials, record NCT01623752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01623752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Evaluation of the Radiographic Efficacy of Enbrel
- NCT number
- NCT01623752
- Status
- Completed
- Enrollment
- 1,821 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis, Psoriasis Arthritis
- Interventions
- Etanercept, Etanercept
- First posted
- 2012-06-20
- Last updated
- 2019-08-16
- Results first posted
- 2019-08-16
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Baseline, Week 78 | To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Baseline, Week 78 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | Baseline, Week 156 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Primary | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | Baseline, Week 156 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Pre-treatment, Week 78 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than \[\>\] 0.5), no change (-0.5 to 0.5) and decrease (less than \[\<\] -0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Pre-treatment, Week 78 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | Pre-treatment, Week 156 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Primary | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | Pre-treatment, Week 156 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Secondary | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Baseline up to Week 78 | Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration. |
| Secondary | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | Baseline up to Week 78 | Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Baseline, Week 78 | Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, Overall Number of Participants Analyzed =number of participants evaluable for this outcome measure; Number Analyzed=number of participants evaluable for the specified time points. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Baseline, Week 78 | Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. Number Analyzed= participants evaluable for the specified time points. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | Baseline, Week 156 | Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | Baseline, Week 156 | Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Units on a scale | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Pre-treatment, Week 78 | Efficacy analysis set for Phase 1 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points. | Scores per year | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Pre-treatment, Week 78 | CAS for phase 1 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and provided data for end of Phase 1 of study. Here, Overall Number of Participants Analyzed=number of participants evaluable for this outcome measure and Number Analyzed=number of participants evaluable for the specified time points. | Scores per year | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | Pre-treatment, Week 156 | Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx3. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Scores per year | MEAN |
| PRIMARY | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | Pre-treatment, Week 156 | CAS for phase 2 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and completed phase 2 of the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Scores per year | MEAN |
| SECONDARY | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Regression coefficient | NUMBER |
| SECONDARY | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | Baseline up to Week 78 | Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows. | Scores per year | LEAST_SQUARES_MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group892
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Participants With Rheumatoid Arthritis | Baseline | 25.1 | Standard Deviation 42.4 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Participants With Psoriatic Arthritis | Baseline | 14.7 | Standard Deviation 25.7 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Participants With Rheumatoid Arthritis | Change at Week 78 | 0.6 | Standard Deviation 7.2 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Participants With Psoriatic Arthritis | Change at Week 78 | -0.4 | Standard Deviation 5.9 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Participants With Rheumatoid Arthritis | Baseline | 25.3 | Standard Deviation 42.5 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Participants With Psoriatic Arthritis | Baseline | 14.7 | Standard Deviation 25.8 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Participants With Rheumatoid Arthritis | Change at Week 78 | 0.6 | Standard Deviation 7.2 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Participants With Psoriatic Arthritis | Change at Week 78 | -0.5 | Standard Deviation 5.8 | Units on a scale |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | Participants With Rheumatoid Arthritis | 1.4 | Standard Deviation 9.9 | Units on a scale | |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | Participants With Psoriatic Arthritis | 0.7 | Standard Deviation 8.2 | Units on a scale |
1 to 10 of 892Source ClinicalTrials.gov
See all 892 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 (78 Weeks) | STARTED | Participants With Rheumatoid Arthritis | 1,378 | |
| Phase 1 (78 Weeks) | STARTED | Participants With Psoriatic Arthritis | 440 | |
| Phase 1 (78 Weeks) | STARTED | Participants With Unclear Diagnosis | 3 | |
| Phase 1 (78 Weeks) | COMPLETED | Participants With Rheumatoid Arthritis | 747 | |
| Phase 1 (78 Weeks) | COMPLETED | Participants With Psoriatic Arthritis | 233 | |
| Phase 1 (78 Weeks) | COMPLETED | Participants With Unclear Diagnosis | 1 | |
| Phase 1 (78 Weeks) | NOT COMPLETED | Participants With Rheumatoid Arthritis | 631 | |
| Phase 1 (78 Weeks) | NOT COMPLETED | Participants With Psoriatic Arthritis | 207 | |
| Phase 1 (78 Weeks) | NOT COMPLETED | Participants With Unclear Diagnosis | 2 | |
| Phase 2 (78 Weeks) | STARTED | Participants With Rheumatoid Arthritis | 291 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,040
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 | Participants With Rheumatoid Arthritis | 4 | 1,378 | |
| other | Anaemia | Blood and lymphatic system disorders | Participants With Psoriatic Arthritis | 0 | 440 | |
| other | Anaemia | Blood and lymphatic system disorders | Participants With Unclear Diagnosis | 0 | 3 | |
| other | Leukopenia | Blood and lymphatic system disorders | Participants With Rheumatoid Arthritis | 1 | 1,378 | |
| other | Leukopenia | Blood and lymphatic system disorders | Participants With Psoriatic Arthritis | 2 | 440 | |
| other | Leukopenia | Blood and lymphatic system disorders | Participants With Unclear Diagnosis | 0 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Participants With Rheumatoid Arthritis | 2 | 1,378 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Participants With Psoriatic Arthritis | 0 | 440 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Participants With Unclear Diagnosis | 0 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Participants With Rheumatoid Arthritis | 1 | 1,378 |
1 to 10 of 2,040Source ClinicalTrials.gov
See all 2,040 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Rheumatoid Arthritis | 6 | 1,378 |
| Total, all-cause mortality | Participants With Psoriatic Arthritis | 0 | 440 |
| Total, all-cause mortality | Participants With Unclear Diagnosis | 0 | 3 |
| Total, other adverse events | Participants With Rheumatoid Arthritis | 579 | 1,378 |
| Total, other adverse events | Participants With Psoriatic Arthritis | 167 | 440 |
| Total, other adverse events | Participants With Unclear Diagnosis | 1 | 3 |
| Total, serious adverse events | Participants With Rheumatoid Arthritis | 159 | 1,378 |
| Total, serious adverse events | Participants With Psoriatic Arthritis | 47 | 440 |
| Total, serious adverse events | Participants With Unclear Diagnosis | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36251174 | DERIVED |
Source PubMed
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/NCT01623752
GET https://conductscience.org/api/trials/v1/NCT01623752/registered?page=2