Trial · NCT00325078
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
NCT00325078, Phase 1, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2015-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease. Trials, record NCT00325078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00325078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
- NCT number
- NCT00325078
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Chronic Granulomatous Disease, Crohn'S-like IBD, Inflammatory Bowel Disease (IBD)
- Interventions
- Infliximab
- First posted
- 2006-05-12
- Last updated
- 2015-12-29
- Results first posted
- 2015-12-29
- Limitations and caveats
Due to limited subject participation and lack of sustained clinical benefits (1 year), there is insufficient complete data to generate meaningful statistics for the outcome measures. Instead, this data are reported as a case series.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Study Drug | Baseline to 1 year | Number of Infections from Baseline to 1 year |
| Primary | Efficacy of Treatment With Study Drug | Baseline, 1 year | Measured participant Crohn's disease Activity Index (CDAI) values. The CDAI is a tool comprised of clinical and laboratory factors such as stool frequency, consistency, abdominal pain, general well being, weight and blood profile as an objective measure of disease activity. A higher score corresponds to greater severity of inflammatory bowel disease; severe disease conventionally defined as \>450, a remission as \<150, and a response to treatment as a fall of CDAI of \>70 points. Infections and IBD are not expected in healthy control subjects. The greater the score, the more severe the disease, and a score of less than 5 represents clinical remission. |
| Other | Gut Immune Cell Types and Their Cytokine Profile | 1 year | Gut Immune cell types and their cytokine profile |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of Study Drug | Baseline to 1 year | The volunteer group includes patients with chronic granulomatous disease as well as healthy normal volunteers as controls. Infection rates only pertain to and are counted in subjects with underlying immunodeficiency (chronic granulomatous disease). | infections | NUMBER |
| PRIMARY | Efficacy of Treatment With Study Drug | Baseline, 1 year | All participants in the Treatment and Observation Arms with collected CDAI data. The CDAI, a tool validated for Crohn's disease is not applicable to healthy donors or CGD patients without IBD, and therefore not measured in the Control participants. | Crohn's disease activity Index | NUMBER |
| OTHER_PRE_SPECIFIED | Gut Immune Cell Types and Their Cytokine Profile | 1 year |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of Study Drug | Treatment | 5 | infections | ||
| Safety of Study Drug | Observation | 4 | infections | ||
| Safety of Study Drug | Control Volunteers | 13 | infections | ||
| Efficacy of Treatment With Study Drug | Treatment | CDAI Value #1 at Baseline | 114.4 | Crohn's disease activity Index | |
| Efficacy of Treatment With Study Drug | Observation | CDAI Value #1 at Baseline | 17.5 | Crohn's disease activity Index | |
| Efficacy of Treatment With Study Drug | Treatment | CDAI Value #2 at Baseline | 191 | Crohn's disease activity Index | |
| Efficacy of Treatment With Study Drug | Observation | CDAI Value #2 at Baseline | 22.5 | Crohn's disease activity Index | |
| Efficacy of Treatment With Study Drug | Treatment | CDAI Value #3 at Baseline | 329.8 | Crohn's disease activity Index | |
| Efficacy of Treatment With Study Drug | Observation | CDAI Value #3 at Baseline | 53 | Crohn's disease activity Index | |
| Efficacy of Treatment With Study Drug | Treatment | CDAI Value #4 at Baseline | 505.2 | Crohn's disease activity Index |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group | 8 | |
| Overall Study | STARTED | Observation Group | 7 | |
| Overall Study | STARTED | Control Volunteer | 25 | |
| Overall Study | COMPLETED | Treatment Group | 3 | |
| Overall Study | COMPLETED | Observation Group | 2 | |
| Overall Study | COMPLETED | Control Volunteer | 23 | |
| Overall Study | NOT COMPLETED | Treatment Group | 5 | |
| Overall Study | NOT COMPLETED | Observation Group | 5 | |
| Overall Study | NOT COMPLETED | Control Volunteer | 2 |
Source ClinicalTrials.gov
Adverse events15
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 | diarrhea (clostridium diff) | Gastrointestinal disorders | Treatment Group | 1 | 8 | |
| other | diarrhea (clostridium diff) | Gastrointestinal disorders | Observation Group | 0 | 7 | |
| other | diarrhea (clostridium diff) | Gastrointestinal disorders | Control Volunteer | 0 | 25 | |
| other | Infusion related reaction | General disorders | Treatment Group | 2 | 8 | |
| other | Infusion related reaction | General disorders | Observation Group | 0 | 7 | |
| other | Infusion related reaction | General disorders | Control Volunteer | 0 | 25 | |
| other | Infections and infestations, IV line infection | Surgical and medical procedures | Treatment Group | 0 | 8 | |
| other | Infections and infestations, IV line infection | Surgical and medical procedures | Observation Group | 1 | 7 | |
| other | Infections and infestations, IV line infection | Surgical and medical procedures | Control Volunteer | 0 | 25 | |
| serious | lung infection | Infections and infestations | Treatment Group | 1 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | ||
| Total, all-cause mortality | Observation Group | ||
| Total, all-cause mortality | Control Volunteer | ||
| Total, other adverse events | Treatment Group | 3 | 8 |
| Total, other adverse events | Observation Group | 1 | 7 |
| Total, other adverse events | Control Volunteer | 0 | 25 |
| Total, serious adverse events | Treatment Group | 2 | 8 |
| Total, serious adverse events | Observation Group | 0 | 7 |
| Total, serious adverse events | Control Volunteer | 0 | 25 |
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 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/NCT00325078
GET https://conductscience.org/api/trials/v1/NCT00325078/results?page=2