Trial · NCT00111917
Beryllium Infliximab Study: Clinical Interventional Trial
NCT00111917, Phase 1, Phase 2, Terminated, Maier, Lisa, M.D.; results first posted 2014-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Beryllium Infliximab Study: Clinical Interventional Trial. Trials, record NCT00111917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00111917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Beryllium Infliximab Study: Clinical Interventional Trial
- NCT number
- NCT00111917
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Maier, Lisa, M.D.
- Conditions
- Berylliosis, Beryllium Disease
- Interventions
- Infliximab, Placebo
- First posted
- 2005-05-27
- Last updated
- 2016-06-02
- Results first posted
- 2014-09-25
- Limitations and caveats
- Although our goal was 20 CBD subjects, only 11 subjects were enrolled, 8:3 in the infliximab:placebo treatment arms as the study was stopped by the sponsor due to slow recruitment.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A-a Gradient at End Exercise | after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen | change in end-exercise A-a gradient |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| POST_HOC | Absolute Numbers of Lymphocytes | after 28 week follow-up | absolute number*10^6/cc | MEDIAN | |
| PRIMARY | A-a Gradient at End Exercise | after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen | Accurate measures were not obtained on all patients at both timepoints. | mmHg | MEDIAN |
| POST_HOC | BAL WBC/cc | after 28 weeks | absolute WBC*10^6/cc | MEDIAN | |
| POST_HOC | BAL % Lymphocytes | after 28 week infusion | percentage of lymphocytes in BAL | MEDIAN |
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 |
|---|---|---|---|---|---|
| Absolute Numbers of Lymphocytes | Infliximab | 1.7 | Standard Error 0.18 | absolute number*10^6/cc | |
| Absolute Numbers of Lymphocytes | Placebo | 1.02 | Standard Error 0.56 | absolute number*10^6/cc | |
| A-a Gradient at End Exercise | Infliximab | 27.3 | Standard Error 10.56 | mmHg | |
| A-a Gradient at End Exercise | Placebo | 94.17 | Standard Error 18.73 | mmHg | |
| BAL WBC/cc | Infliximab | 0.23 | Standard Deviation 0.04 | absolute WBC*10^6/cc | |
| BAL WBC/cc | Placebo | 0.25 | Standard Deviation 0.03 | absolute WBC*10^6/cc | |
| BAL % Lymphocytes | Group 1 | 4.68 | Standard Deviation 7.84 | percentage of lymphocytes in BAL | |
| BAL % Lymphocytes | Group 2 | 14.7 | Standard Deviation 0 | percentage of lymphocytes in BAL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 - Infliximab | 9 | |
| Overall Study | STARTED | Group 2 - Placebo | 4 | |
| Overall Study | COMPLETED | Group 1 - Infliximab | 8 | |
| Overall Study | COMPLETED | Group 2 - Placebo | 3 | |
| Overall Study | NOT COMPLETED | Group 1 - Infliximab | 1 | |
| Overall Study | NOT COMPLETED | Group 2 - Placebo | 1 |
Source ClinicalTrials.gov
Adverse events8
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 |
|---|---|---|---|---|---|---|
| serious | Acute cholecystitis | Hepatobiliary disorders | Group 1 - Infliximab | 1 | 8 | 1 |
| serious | Acute cholecystitis | Hepatobiliary disorders | Group 2 - Placebo | 0 | 3 | 0 |
| serious | Nausea, vomiting | Gastrointestinal disorders | Group 1 - Infliximab | 1 | 8 | 1 |
| serious | Nausea, vomiting | Gastrointestinal disorders | Group 2 - Placebo | 0 | 3 | 0 |
| serious | liver function levels | Hepatobiliary disorders | Group 1 - Infliximab | 1 | 8 | 1 |
| serious | liver function levels | Hepatobiliary disorders | Group 2 - Placebo | 0 | 3 | 0 |
| serious | Kidney stone | Renal and urinary disorders | Group 1 - Infliximab | 0 | 8 | 0 |
| serious | Kidney stone | Renal and urinary disorders | Group 2 - Placebo | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 - Infliximab | ||
| Total, all-cause mortality | Group 2 - Placebo | ||
| Total, other adverse events | Group 1 - Infliximab | 0 | 8 |
| Total, other adverse events | Group 2 - Placebo | 0 | 3 |
| Total, serious adverse events | Group 1 - Infliximab | 3 | 8 |
| Total, serious adverse events | Group 2 - Placebo | 1 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22974830 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1RR025780 | Colorado Clinical and Translational Science Institute (UL1) | SOKOL, RONALD J. | UNIVERSITY OF COLORADO DENVER | NATIONAL CENTER FOR RESEARCH RESOURCES | 2008 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 - Infliximab vs Group 2 - Placebo: serious adverse events |
Source Trial comparisons
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/NCT00111917
GET https://conductscience.org/api/trials/v1/NCT00111917/registered