Trial · NCT00259610
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
NCT00259610, Phase 4, Completed, University of Alabama at Birmingham; results first posted 2014-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Early Aggressive Rheumatoid Arthritis (TEAR). Trials, record NCT00259610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00259610
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
- NCT number
- NCT00259610
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 755 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Rheumatoid Arthritis
- Interventions
- methotrexate, sulfasalazine, hydroxychloroquine, etanercept
- First posted
- 2005-11-29
- Last updated
- 2014-07-17
- Results first posted
- 2014-07-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) | Change of the Mean of DAS28-ESR between weeks 48 - 102. | Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH. The ESR is the rate at which red blood cells sediment in a period of one hour. The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. |
| Secondary | Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. | Year 2, Week 102 | Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) | Change of the Mean of DAS28-ESR between weeks 48 - 102. | The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis. | Scores on a scale | MEAN |
| SECONDARY | Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. | Year 2, Week 102 | The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) | MTX + Immediate Etanercept | 3.0 | Standard Deviation 1.4 | Scores on a scale | |
| Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) | MTX+ Immediate SSZ +HCQ | 2.9 | Standard Deviation 1.5 | Scores on a scale | |
| Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) | MTX + Step-up Etanercept | 3.1 | Standard Deviation 1.4 | Scores on a scale | |
| Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) | MTX + Step-up SSZ + HCQ(ST) | 2.8 | Standard Deviation 1.3 | Scores on a scale | |
| Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. | MTX + Immediate Etanercept | 7.0 | Standard Deviation 16.6 | Scores on a scale | |
| Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. | MTX+ Immediate SSZ +HCQ | 7.3 | Standard Deviation 13.3 | Scores on a scale | |
| Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. | MTX + Step-up Etanercept | 4.8 | Standard Deviation 7.2 | Scores on a scale | |
| Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores. | MTX + Step-up SSZ + HCQ(ST) | 6.2 | Standard Deviation 8.9 | Scores 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 | MTX + Active Etanercept | 244 | |
| Overall Study | STARTED | MTX+ Active SSZ +HCQ | 132 | |
| Overall Study | STARTED | MTX + Placebo Entaneracept | 255 | |
| Overall Study | STARTED | MTX + Placebo SSZ + HCQ(ST) | 124 | |
| Overall Study | COMPLETED | MTX + Active Etanercept | 168 | |
| Overall Study | COMPLETED | MTX+ Active SSZ +HCQ | 86 | |
| Overall Study | COMPLETED | MTX + Placebo Entaneracept | 182 | |
| Overall Study | COMPLETED | MTX + Placebo SSZ + HCQ(ST) | 81 | |
| Overall Study | NOT COMPLETED | MTX + Active Etanercept | 76 | |
| Overall Study | NOT COMPLETED | MTX+ Active SSZ +HCQ | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,052
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 | Anemia | Blood and lymphatic system disorders | MTX + Active Etanercept | 0 | 244 | 0 |
| other | Anemia | Blood and lymphatic system disorders | MTX+ Active SSZ +HCQ | 1 | 132 | 1 |
| other | Anemia | Blood and lymphatic system disorders | MTX + Placebo Entaneracept | 0 | 255 | 0 |
| other | Anemia | Blood and lymphatic system disorders | MTX + Placebo SSZ + HCQ(ST) | 0 | 124 | 0 |
| other | Edema | Blood and lymphatic system disorders | MTX + Active Etanercept | 8 | 244 | 8 |
| other | Edema | Blood and lymphatic system disorders | MTX+ Active SSZ +HCQ | 3 | 132 | 3 |
| other | Edema | Blood and lymphatic system disorders | MTX + Placebo Entaneracept | 7 | 255 | 7 |
| other | Edema | Blood and lymphatic system disorders | MTX + Placebo SSZ + HCQ(ST) | 2 | 124 | 2 |
| other | Nose Bleed | Blood and lymphatic system disorders | MTX + Active Etanercept | 2 | 244 | 2 |
| other | Nose Bleed | Blood and lymphatic system disorders | MTX+ Active SSZ +HCQ | 0 | 132 | 0 |
1 to 10 of 1,052Source ClinicalTrials.gov
See all 1,052 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MTX + Active Etanercept | ||
| Total, all-cause mortality | MTX+ Active SSZ +HCQ | ||
| Total, all-cause mortality | MTX + Placebo Entaneracept | ||
| Total, all-cause mortality | MTX + Placebo SSZ + HCQ(ST) | ||
| Total, other adverse events | MTX + Active Etanercept | 184 | 244 |
| Total, other adverse events | MTX+ Active SSZ +HCQ | 99 | 132 |
| Total, other adverse events | MTX + Placebo Entaneracept | 180 | 255 |
| Total, other adverse events | MTX + Placebo SSZ + HCQ(ST) | 89 | 124 |
| Total, serious adverse events | MTX + Active Etanercept | 35 | 244 |
| Total, serious adverse events | MTX+ Active SSZ +HCQ | 18 | 132 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00259610
GET https://conductscience.org/api/trials/v1/NCT00259610/events?page=2