Trial · NCT00405275
Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy
NCT00405275, Not applicable, Completed, US Department of Veterans Affairs; results first posted 2013-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy. Trials, record NCT00405275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405275
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy
- NCT number
- NCT00405275
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 353 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Rheumatoid Arthritis
- Interventions
- Etanercept, methotrexate, Sulfasalazine, Hydroxychloroquine, Placebo, triple, Placebo, etanercept
- First posted
- 2006-11-30
- Last updated
- 2013-12-03
- Results first posted
- 2013-12-03
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean 48-week Change in DAS28 | 48 weeks after baseline assessment | Average difference between 48-week and Baseline DAS28. The Disease Activity Score for 28 Joints (DAS28) is a well-validated composite outcome measure ranging from 2-10 (higher scores indicating more disease) that incorporates a tender and swollen joint count of 28 joints, a laboratory measure of systemic inflammation (ESR) and a patient-reported general assessment of health on a visual analog scale (ranging from 0-10cm) all into one measure. Low disease activity is defined as DAS28 ≤ 3.2 units. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean 48-week Change in DAS28 | 48 weeks after baseline assessment | Intention to treat analysis was performed on participants with Week 48 DAS28 data. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean 48-week Change in DAS28 | Triple | -2.12 | Standard Deviation 1.28 | units on a scale | |
| Mean 48-week Change in DAS28 | Etanercept | -2.29 | Standard Deviation 1.30 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triple | 178 | |
| Overall Study | STARTED | Etanercept | 175 | |
| Overall Study | 24 Weeks (Total) | Triple | 163 | |
| Overall Study | 24 Weeks (Total) | Etanercept | 165 | |
| Overall Study | 24 Week (no Switch) | Triple | 119 | |
| Overall Study | 24 Week (no Switch) | Etanercept | 121 | |
| Overall Study | 24 Week (Switch) | Triple | 44 | |
| Overall Study | 24 Week (Switch) | Etanercept | 44 | |
| Overall Study | COMPLETED | Triple | 155 | |
| Overall Study | COMPLETED | Etanercept | 156 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events192
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 | Nausea | Gastrointestinal disorders | Triple | 16 | 222 | 23 |
| other | Nausea | Gastrointestinal disorders | Etanercept | 17 | 219 | 18 |
| other | Nasopharyngitis | Infections and infestations | Triple | 8 | 222 | 8 |
| other | Nasopharyngitis | Infections and infestations | Etanercept | 14 | 219 | 16 |
| other | Upper respiratory tract infection | Infections and infestations | Triple | 12 | 222 | 17 |
| other | Upper respiratory tract infection | Infections and infestations | Etanercept | 19 | 219 | 23 |
| other | Headache | Nervous system disorders | Triple | 17 | 222 | 20 |
| other | Headache | Nervous system disorders | Etanercept | 14 | 219 | 15 |
| serious | Anaemia | Blood and lymphatic system disorders | Triple | 0 | 222 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Etanercept | 1 | 219 | 1 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triple | ||
| Total, all-cause mortality | Etanercept | ||
| Total, other adverse events | Triple | 40 | 222 |
| Total, other adverse events | Etanercept | 55 | 219 |
| Total, serious adverse events | Triple | 38 | 222 |
| Total, serious adverse events | Etanercept | 43 | 219 |
Source ClinicalTrials.gov
Papers4
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 |
|---|
| Triple vs Etanercept: 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/NCT00405275
GET https://conductscience.org/api/trials/v1/NCT00405275/events?page=2