Trial · NCT00848354
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
NCT00848354, Phase 4, Completed, Pfizer; results first posted 2012-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy. Trials, record NCT00848354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
- NCT number
- NCT00848354
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 429 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- Phase 1: Etanercept, Phase 1: Methotrexate, Phase 2: Optional ETN, SSZ, HCQ, MTX, Phase 1: Methotrexate, Phase 1: Conventiaonal DMARD
- First posted
- 2009-02-20
- Last updated
- 2016-01-18
- Results first posted
- 2012-04-19
Source ClinicalTrials.gov
Registered outcomes71
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | Week 24 | ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP). |
| Secondary | Change From Baseline in HAQ Score at Week 24 | Baseline and Week 24 | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation. |
| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Secondary | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Baseline and Week 24 | mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Secondary | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28\<3.2 indicates low disease activity and DAS28\<2.6 remission. |
| Secondary | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28\<3.2 indicates low disease activity and DAS28\<2.6 remission. |
| Secondary | Summary of Changes in Therapy at the Beginning of Phase 2 | Week 24 | The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized. |
| Secondary | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP. |
| Secondary | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR. |
| Secondary | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP. |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 registered outcomesOutcomes71
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | Week 24 | Modified intent-to-treat (mITT) population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. Last Observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HAQ Score at Week 24 | Baseline and Week 24 | mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline and Week 24 | mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Baseline and Week 24 | Radiographic intent-to-treat (xITT) population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120). | units on a scale | MEAN |
| SECONDARY | Summary of Changes in Therapy at the Beginning of Phase 2 | Week 24 | mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. One participant was randomized to etanercept but received SSZ in Phase 1. | participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. | percentage of participants | NUMBER |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 outcomesResults by group866
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | Etanercept + Methotrexate | 62.01 | Percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | DMARD + Methotrexate | 23.24 | Percentage of participants | ||
| Change From Baseline in HAQ Score at Week 24 | Etanercept + Methotrexate | Baseline | 1.55 | Standard Error 0.05 | Units on a scale |
| Change From Baseline in HAQ Score at Week 24 | DMARD + Methotrexate | Baseline | 1.51 | Standard Error 0.07 | Units on a scale |
| Change From Baseline in HAQ Score at Week 24 | Etanercept + Methotrexate | Change at Week 24 | -0.85 | Standard Error 0.04 | Units on a scale |
| Change From Baseline in HAQ Score at Week 24 | DMARD + Methotrexate | Change at Week 24 | -0.51 | Standard Error 0.06 | Units on a scale |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Etanercept + Methotrexate | Baseline, Vitality domain | 12.46 | Standard Error 0.28 | Units on a scale |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | DMARD + Methotrexate | Baseline, Vitality domain | 12.39 | Standard Error 0.36 | Units on a scale |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Etanercept + Methotrexate | Baseline, Mental component | 40.50 | Standard Error 0.78 | Units on a scale |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | DMARD + Methotrexate | Baseline, Mental component | 40.41 | Standard Error 1.00 | Units on a scale |
1 to 10 of 866Source ClinicalTrials.gov
See all 866 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Etanercept + Methotrexate | 281 | |
| Phase 1 | STARTED | DMARD + Methotrexate | 143 | |
| Phase 1 | COMPLETED | Etanercept + Methotrexate | 269 | |
| Phase 1 | COMPLETED | DMARD + Methotrexate | 129 | |
| Phase 1 | NOT COMPLETED | Etanercept + Methotrexate | 12 | |
| Phase 1 | NOT COMPLETED | DMARD + Methotrexate | 14 | |
| Phase 2 Year 1 | STARTED | Etanercept + Methotrexate | 260 | |
| Phase 2 Year 1 | STARTED | DMARD + Methotrexate | 126 | |
| Phase 2 Year 1 | COMPLETED | Etanercept + Methotrexate | 242 | |
| Phase 2 Year 1 | COMPLETED | DMARD + Methotrexate | 120 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events372
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 | Dyspepsia | Gastrointestinal disorders | Etanercept + Methotrexate Phase 1 | 6 | 281 | |
| other | Dyspepsia | Gastrointestinal disorders | DMARD + Methotrexate Phase 1 | 9 | 143 | |
| other | Dyspepsia | Gastrointestinal disorders | Etanercept + Methotrexate Phase 2 Year 1 | 3 | 260 | |
| other | Dyspepsia | Gastrointestinal disorders | DMARD + Methotrexate Phase 2 Year 1 | 2 | 126 | |
| other | Dyspepsia | Gastrointestinal disorders | Etanercept + Methotrexate Phase 2 Year 2 | 3 | 241 | |
| other | Dyspepsia | Gastrointestinal disorders | DMARD + Methotrexate Phase 2 Year 2 | 0 | 120 | |
| other | Gastritis | Gastrointestinal disorders | Etanercept + Methotrexate Phase 1 | 5 | 281 | |
| other | Gastritis | Gastrointestinal disorders | DMARD + Methotrexate Phase 1 | 9 | 143 | |
| other | Gastritis | Gastrointestinal disorders | Etanercept + Methotrexate Phase 2 Year 1 | 5 | 260 | |
| other | Gastritis | Gastrointestinal disorders | DMARD + Methotrexate Phase 2 Year 1 | 2 | 126 |
1 to 10 of 372Source ClinicalTrials.gov
See all 372 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept + Methotrexate Phase 1 | ||
| Total, all-cause mortality | DMARD + Methotrexate Phase 1 | ||
| Total, all-cause mortality | Etanercept + Methotrexate Phase 2 Year 1 | ||
| Total, all-cause mortality | DMARD + Methotrexate Phase 2 Year 1 | ||
| Total, all-cause mortality | Etanercept + Methotrexate Phase 2 Year 2 | ||
| Total, all-cause mortality | DMARD + Methotrexate Phase 2 Year 2 | ||
| Total, other adverse events | Etanercept + Methotrexate Phase 1 | 64 | 281 |
| Total, other adverse events | DMARD + Methotrexate Phase 1 | 41 | 143 |
| Total, other adverse events | Etanercept + Methotrexate Phase 2 Year 1 | 19 | 260 |
| Total, other adverse events | DMARD + Methotrexate Phase 2 Year 1 | 19 | 126 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
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/NCT00848354
GET https://conductscience.org/api/trials/v1/NCT00848354/registered?page=2