Trial · NCT02413047
Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
NCT02413047, Not applicable, Terminated, Indiana University; results first posted 2019-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator. Trials, record NCT02413047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02413047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
- NCT number
- NCT02413047
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 3 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- Interventions
- Azathioprine, 6 mercaptopurine, Methotrexate
- First posted
- 2015-04-09
- Last updated
- 2019-11-04
- Results first posted
- 2019-11-04
- Limitations and caveats
- The study terminated early due to low subject enrollment. Since only 3 patients were enrolled, study analysis was not possible for measurable outcomes.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Harvey Bradshaw Index HBI: Decrease >3 Points or Remission Score<5 | 4 months | The Harvey-Bradshaw index (HBI) is a simplified version of the CDAI to foster a systematic collection of clinical data related to Crohn's disease. The index considers five parameters, exclusively clinical; patient well-being, abdominal pain, number of liquid or soft stools, abdominal mass, and complications. |
| Primary | Therapeutic Trough Level for Infliximab is Defined as >3 and as > 5 for Adalimumab. | 4 months | Trough level is the lowest level of drug detected in a subject prior to next dose of medication |
| Primary | Ulcerative Colitis Clinical Score UCCS Decrease >3 Points or Remission Score <3 | 4 months | UCCS is the ulcerative colitis clinical score which is based on disease activity. The score is based on bowel movements, blood in stool, overall well being, and global assessment. |
| Primary | Change Inflammatory Bowel Disease Questionnaire SIBDQ | 4 months | SIBDQ is the short inflammatory bowel disease questionnaire which is a health-related quality of life tool measuring physical, social, and emotional status. |
| Primary | Eliminate Antibodies: Threshold Levels for ATI is < 3.1and is < 1.7 for ADA. | 4 months | unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug antibodies inactivating the therapeutic effects of the treatment. |
| Secondary | Improvement or Normalization of Mayo Endoscopy Score for UC Patients | 4 months | Mayo endoscopy score is scoring completed during the endoscopy to evaluate disease activity. Scoring is based on stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician rating of disease activity |
| Secondary | Improvement or Normalization of C-reactive Protein, Sedimentation Rate and Fecal Calprotectin | 4 months | c-reactive protein, sedimentation rate, and fecal calprotectin were collected to monitor the level of inflammation in the subject. Improvement was determined if inflammation level was reduced. |
| Secondary | Improvement or Normalization of the Simple Endoscopic Score-Crohn's Disease (SES-CD) | 4 months | SESCD is the simple endoscopic score for crohn's disease patients scored during endoscopy. The scoring is based on appearance of ulcers/sizing, % of ulcerative surface, % of affected surface, and if there were any narrowings or strictures found. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Harvey Bradshaw Index HBI: Decrease >3 Points or Remission Score<5 | 4 months | Not enough subjects for analysis | ||
| PRIMARY | Therapeutic Trough Level for Infliximab is Defined as >3 and as > 5 for Adalimumab. | 4 months | Not enough subjects for analysis | ||
| PRIMARY | Ulcerative Colitis Clinical Score UCCS Decrease >3 Points or Remission Score <3 | 4 months | Not enough subjects for analysis | ||
| PRIMARY | Change Inflammatory Bowel Disease Questionnaire SIBDQ | 4 months | Not enough subjects for analysis | ||
| PRIMARY | Eliminate Antibodies: Threshold Levels for ATI is < 3.1and is < 1.7 for ADA. | 4 months | Not enough subjects for analysis | ||
| SECONDARY | Improvement or Normalization of Mayo Endoscopy Score for UC Patients | 4 months | Not enough subjects for analysis | ||
| SECONDARY | Improvement or Normalization of C-reactive Protein, Sedimentation Rate and Fecal Calprotectin | 4 months | Not enough subjects for analysis | ||
| SECONDARY | Improvement or Normalization of the Simple Endoscopic Score-Crohn's Disease (SES-CD) | 4 months | Not enough subjects for analysis |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Immunomodulator | 3 | |
| Overall Study | Participants on Infliximab | Immunomodulator | 2 | |
| Overall Study | Participants on Adalimumab | Immunomodulator | 1 | |
| Overall Study | COMPLETED | Immunomodulator | 3 | |
| Overall Study | NOT COMPLETED | Immunomodulator | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immunomodulator | 0 | 3 |
| Total, other adverse events | Immunomodulator | 0 | 3 |
| Total, serious adverse events | Immunomodulator | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02413047
GET https://conductscience.org/api/trials/v1/NCT02413047/registered