Trial · NCT03139032
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exploratory Endpoint - Change From Baseline in Endoscopic Improvement/Histologic Healing Using Endoscopy or Flexible Proctosigmoidoscopy | Weeks 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Level of Fecal Calprotectin | Weeks 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Extra-intestinal Manifestations (EIM) (PG, EN and Psoriasis) | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin EIM | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in the Dermatology Life Quality Index Score | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Inflammatory Bowel Disease Questionnaire Score | Weeks 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in C-reactive Protein | Weeks 1, 2, 4, 8, 12 and the 2-week follow-up visit | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Leucocyte Characterization | Weeks 8 and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Stool Frequency at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Rectal Bleeding at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Physicians Global Assessments at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Lymphocyte Counts | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Disease Activity Score at Crohn's Disease Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Change From Baseline in Psoriasis Area and Severity Index at Psoriasis Endpoint | Weeks 1, 2, 4, 8, and 12 | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint - Changes in Degree of Immune Cell Infiltration as Assessed From Skin Punch Biopsies (From Healthy Skin and From Target Lesion) | Weeks -1, 8, and 12. | Efficacy analyses were not conducted due to low enrollment (N=1). To protect participant's privacy, the results from a single participant cannot be reported. | ||
| PRIMARY | Exploratory Endpoint -Changes in Levels of Cytokine Expression as Assessed From Skin Punch Biopsies (From Healthy Skin and From Target Lesion) | Weeks -1, 8 and 12. | Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported. | ||
| OTHER_PRE_SPECIFIED | Safety Measured by Number of Participants With Adverse Events and Serious Adverse Events | From date of first dose of study treatment to the safety follow-up visit, approximately 14 weeks | There were no analysis populations in the single participant study. Safety results for the single participant are reported. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03139032/outcomes