Trial · NCT00234884
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
NCT00234884, Completed, Abbott; results first posted 2011-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post-marketing Observational Study in Subjects With Rheumatoid Arthritis. Trials, record NCT00234884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00234884
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
- NCT number
- NCT00234884
- Status
- Completed
- Enrollment
- 3,435 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Rheumatoid Arthritis
- Interventions
- adalimumab
- First posted
- 2005-10-10
- Last updated
- 2011-09-30
- Results first posted
- 2011-09-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR. |
| Primary | American College of Rheumatology 20% (ACR20) Response Rate | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497). |
| Primary | American College of Rheumatology 50% (ACR50) Response Rate | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497). |
| Primary | American College of Rheumatology 70% (ACR70) Response Rate | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497). |
| Primary | Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | Results are presented as observed. The number of participants evaluated is indicated for each time point below. | units on a scale | MEAN |
| PRIMARY | American College of Rheumatology 20% (ACR20) Response Rate | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | Results are presented as observed. The number of participants evaluated is indicated for each time point below. | percentage of participants | NUMBER |
| PRIMARY | American College of Rheumatology 50% (ACR50) Response Rate | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | Results are presented as observed. The number of participants evaluated is indicated for each time point below. | percentage of participants | NUMBER |
| PRIMARY | American College of Rheumatology 70% (ACR70) Response Rate | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | Results are presented as observed. The number of participants evaluated is indicated for each time point below. | participants | NUMBER |
| PRIMARY | Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value | Results are presented as observed. The number of participants evaluated is indicated for each time point below. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Baseline of NCT00448383 (Study M02-497) (N = 3407) | 6.0 | Standard Deviation 1.1 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Baseline of NCT00234884 (Study M03-634) (N = 2746) | 3.3 | Standard Deviation 1.3 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Month 12 (N = 2430) | 3.1 | Standard Deviation 1.3 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Month 24 (N = 2033) | 3.0 | Standard Deviation 1.3 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Month 36 (N = 1746) | 3.0 | Standard Deviation 1.2 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Month 48 (N = 1518) | 2.9 | Standard Deviation 1.2 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Month 60 (N = 1255) | 2.8 | Standard Deviation 1.2 | units on a scale |
| Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) | Adalimumab | Last Observed Value (N = 3281) | 3.3 | Standard Deviation 1.5 | units on a scale |
| American College of Rheumatology 20% (ACR20) Response Rate | Adalimumab | Baseline of NCT00234884 (Study M03-634) (N = 2886) | 80.3 | percentage of participants | |
| American College of Rheumatology 20% (ACR20) Response Rate | Adalimumab | Month 12 (N = 2508) | 82.9 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab | 3,435 | |
| Overall Study | COMPLETED | Adalimumab | 1,805 | |
| Overall Study | NOT COMPLETED | Adalimumab | 1,630 |
Source ClinicalTrials.gov
Adverse events544
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 | Bronchitis | Infections and infestations | Adalimumab | 244 | 3,435 | |
| other | Nasopharyngitis | Infections and infestations | Adalimumab | 189 | 3,435 | |
| other | Urinary tract infection | Infections and infestations | Adalimumab | 195 | 3,435 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | Adalimumab | 1 | 3,435 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Adalimumab | 5 | 3,435 | 5 |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Adalimumab | 1 | 3,435 | 1 |
| serious | Hypereosinophilic syndrome | Blood and lymphatic system disorders | Adalimumab | 1 | 3,435 | 1 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Adalimumab | 2 | 3,435 | 2 |
| serious | Leukopenia | Blood and lymphatic system disorders | Adalimumab | 2 | 3,435 | 2 |
| serious | Lymphoadenopathy | Blood and lymphatic system disorders | Adalimumab | 2 | 3,435 | 2 |
1 to 10 of 544Source ClinicalTrials.gov
See all 544 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab | ||
| Total, other adverse events | Adalimumab | 562 | 3,435 |
| Total, serious adverse events | Adalimumab | 755 | 3,435 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24460746 | 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/NCT00234884
GET https://conductscience.org/api/trials/v1/NCT00234884/results?page=2