Trial · NCT00705484
European Safety Registry in Ulcerative Colitis (P04808)
NCT00705484, Completed, Merck Sharp & Dohme LLC; results first posted 2018-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. European Safety Registry in Ulcerative Colitis (P04808). Trials, record NCT00705484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- European Safety Registry in Ulcerative Colitis (P04808)
- NCT number
- NCT00705484
- Status
- Completed
- Enrollment
- 2,239 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Ulcerative Colitis
- Interventions
- infliximab, Standard Therapy
- First posted
- 2008-06-26
- Last updated
- 2018-08-27
- Results first posted
- 2018-07-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Up to 5 years. | The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities. |
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 | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Up to 5 years. | All enrolled participants. The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Remicade Group | Serious Infection | 9.1 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Standard Therapy Group | Serious Infection | 3.4 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Switched to Remicade Group | Serious Infection | 10.5 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Remicade Group | Infusion-Related Reactions | 13.0 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Standard Therapy Group | Infusion-Related Reactions | 0.2 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Switched to Remicade Group | Infusion-Related Reactions | 8.8 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Remicade Group | Congestive Heart Failure | 0.3 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Standard Therapy Group | Congestive Heart Failure | 0.3 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Switched to Remicade Group | Congestive Heart Failure | 0.3 | Percentage of participants | |
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Remicade Group | Demyelinating Neurological Disorders | 0.1 | Percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Remicade Group | 1,059 | |
| Overall Study | STARTED | Standard Therapy Group | 1,180 | |
| Overall Study | Follow-up Period | Remicade Group | 1,059 | |
| Overall Study | Follow-up Period | Standard Therapy Group | 296 | |
| Overall Study | COMPLETED | Remicade Group | 677 | |
| Overall Study | COMPLETED | Standard Therapy Group | 772 | |
| Overall Study | NOT COMPLETED | Remicade Group | 382 | |
| Overall Study | NOT COMPLETED | Standard Therapy Group | 408 |
Source ClinicalTrials.gov
Adverse events1,611
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 | Colitis Ulcerative | Gastrointestinal disorders | Remicade Group | 213 | 1,059 | 314 |
| other | Colitis Ulcerative | Gastrointestinal disorders | Standard Therapy Group | 145 | 1,180 | 207 |
| other | Colitis Ulcerative | Gastrointestinal disorders | Switched to Remicade Group | 51 | 296 | 75 |
| other | Nasopharyngitis | Infections and infestations | Remicade Group | 64 | 1,059 | 79 |
| other | Nasopharyngitis | Infections and infestations | Standard Therapy Group | 23 | 1,180 | 25 |
| other | Nasopharyngitis | Infections and infestations | Switched to Remicade Group | 9 | 296 | 9 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Remicade Group | 95 | 1,059 | 116 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Standard Therapy Group | 24 | 1,180 | 28 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Switched to Remicade Group | 17 | 296 | 20 |
| serious | Anaemia | Blood and lymphatic system disorders | Remicade Group | 6 | 1,059 | 6 |
1 to 10 of 1,611Source ClinicalTrials.gov
See all 1,611 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remicade Group | ||
| Total, all-cause mortality | Standard Therapy Group | ||
| Total, all-cause mortality | Switched to Remicade Group | ||
| Total, other adverse events | Remicade Group | 321 | 1,059 |
| Total, other adverse events | Standard Therapy Group | 173 | 1,180 |
| Total, other adverse events | Switched to Remicade Group | 70 | 296 |
| Total, serious adverse events | Remicade Group | 439 | 1,059 |
| Total, serious adverse events | Standard Therapy Group | 294 | 1,180 |
| Total, serious adverse events | Switched to Remicade Group | 102 | 296 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30809631 | 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/NCT00705484
GET https://conductscience.org/api/trials/v1/NCT00705484/results?page=2