Trial · NCT00422227
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
NCT00422227, Phase 4, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2010-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region. Trials, record NCT00422227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422227
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
- NCT number
- NCT00422227
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 300 participants, actual
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- Etanercept , Methotrexate, Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
- First posted
- 2007-01-15
- Last updated
- 2010-08-30
- Results first posted
- 2010-08-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks | 16 weeks | ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening. The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks. |
| Secondary | Percentage of Participants Achieving ACR 20, 50, and 70 Responses | Week 16 | Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability. |
| Secondary | Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) | Week 16 | Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm). |
| Secondary | Percent Change From Baseline in DAS28 at Week 16 | Week 16 | Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm). |
| Secondary | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response | Week 16 | EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as \>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \>0.6 but ≤1.2 and DAS attained during follow-up of \>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response. |
| Secondary | Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2 | Week 16 | Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm). |
| Secondary | Percent Change From Baseline in Painful and Swollen Joint Counts | Week 2, 4, 8, 12, 16 | Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen. |
| Secondary | Percent Change From Baseline in Physician And Subject Global Assessments | Week 2, 4, 8, 12, 16 | The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity. |
| Secondary | Percent Change From Baseline in Duration (Minutes) of Morning Stiffness | Week 2, 4, 8, 12, 16 | The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded. |
| Secondary | Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales | Week 2, 4, 8, 12, 16 | VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, "in general how would you rate your heath over the last 2-3 weeks", 0mm equals very well and 100mm equals extremely bad. Pain VAS: "indicate the amount of pain experienced during the last 2-3 days", 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: "how fatigued or tired have you been over the last week", range =No Fatigue - Extremely Fatigued. |
Source ClinicalTrials.gov
Outcomes10
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 Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks | 16 weeks | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving ACR 20, 50, and 70 Responses | Week 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) | Week 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in DAS28 at Week 16 | Week 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percent change | NUMBER |
| SECONDARY | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response | Week 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2 | Week 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Painful and Swollen Joint Counts | Week 2, 4, 8, 12, 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percent change | NUMBER |
| SECONDARY | Percent Change From Baseline in Physician And Subject Global Assessments | Week 2, 4, 8, 12, 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percent change | NUMBER |
| SECONDARY | Percent Change From Baseline in Duration (Minutes) of Morning Stiffness | Week 2, 4, 8, 12, 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percent change | NUMBER |
| SECONDARY | Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales | Week 2, 4, 8, 12, 16 | The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment. | Percent change | NUMBER |
Source ClinicalTrials.gov
Results by group100
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 Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks | ETN/MTX | 434.83 | Standard Error 29.18 | Units on a scale | |
| Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks | DMARD/MTX | 289.54 | Standard Error 36.11 | Units on a scale | |
| Percentage of Participants Achieving ACR 20, 50, and 70 Responses | ETN/MTX | ACR 20 | 78.87 | Percentage of Participants | |
| Percentage of Participants Achieving ACR 20, 50, and 70 Responses | DMARD/MTX | ACR 20 | 58.16 | Percentage of Participants | |
| Percentage of Participants Achieving ACR 20, 50, and 70 Responses | ETN/MTX | ACR 50 | 56.70 | Percentage of Participants | |
| Percentage of Participants Achieving ACR 20, 50, and 70 Responses | DMARD/MTX | ACR 50 | 34.69 | Percentage of Participants | |
| Percentage of Participants Achieving ACR 20, 50, and 70 Responses | ETN/MTX | ACR 70 | 19.07 | Percentage of Participants | |
| Percentage of Participants Achieving ACR 20, 50, and 70 Responses | DMARD/MTX | ACR 70 | 7.14 | Percentage of Participants | |
| Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) | ETN/MTX | Low Disease (DAS28 <3.2) | 39.09 | Percentage of Participants | |
| Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) | DMARD/MTX | Low Disease (DAS28 <3.2) | 18.45 | Percentage of Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ETN/MTX | 197 | |
| Overall Study | STARTED | DMARD/MTX | 103 | |
| Overall Study | COMPLETED | ETN/MTX | 193 | |
| Overall Study | COMPLETED | DMARD/MTX | 88 | |
| Overall Study | NOT COMPLETED | ETN/MTX | 4 | |
| Overall Study | NOT COMPLETED | DMARD/MTX | 15 |
Source ClinicalTrials.gov
Adverse events42
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 | Leukopenia | Blood and lymphatic system disorders | ETN/MTX | 4 | 197 | |
| other | Leukopenia | Blood and lymphatic system disorders | DMARD/MTX | 8 | 103 | |
| other | Nausea | Gastrointestinal disorders | ETN/MTX | 4 | 197 | |
| other | Nausea | Gastrointestinal disorders | DMARD/MTX | 8 | 103 | |
| other | Pyrexia | General disorders | ETN/MTX | 6 | 197 | |
| other | Pyrexia | General disorders | DMARD/MTX | 6 | 103 | |
| other | Upper respiratory tract infection | Infections and infestations | ETN/MTX | 27 | 197 | |
| other | Upper respiratory tract infection | Infections and infestations | DMARD/MTX | 16 | 103 | |
| other | Alanine aminotransferase increased | Investigations | ETN/MTX | 11 | 197 | |
| other | Alanine aminotransferase increased | Investigations | DMARD/MTX | 15 | 103 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ETN/MTX | ||
| Total, all-cause mortality | DMARD/MTX | ||
| Total, other adverse events | ETN/MTX | 66 | 197 |
| Total, other adverse events | DMARD/MTX | 71 | 103 |
| Total, serious adverse events | ETN/MTX | 6 | 197 |
| Total, serious adverse events | DMARD/MTX | 3 | 103 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ETN/MTX vs DMARD/MTX: serious adverse events |
Source Trial comparisons
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/NCT00422227
GET https://conductscience.org/api/trials/v1/NCT00422227/results?page=2