Trial · NCT03139032
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exploratory Endpoint - Change From Baseline in Endoscopic Improvement/Histologic Healing Using Endoscopy or Flexible Proctosigmoidoscopy | Weeks 12 | Only if there are signs of inflammation at screening another evaluation was planned to be performed at week 12. |
| Primary | Exploratory Endpoint - Change From Baseline in Level of Fecal Calprotectin | Weeks 4, 8, and 12 | |
| 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 | |
| Primary | Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin EIM | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in the Dermatology Life Quality Index Score | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Inflammatory Bowel Disease Questionnaire Score | Weeks 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in C-reactive Protein | Weeks 1, 2, 4, 8, 12 and the 2-week follow-up visit | |
| Primary | Exploratory Endpoint - Change From Baseline in Leucocyte Characterization | Weeks 8 and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Stool Frequency at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Rectal Bleeding at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Physicians Global Assessments at Ulcerative Colitis Endpoint | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Lymphocyte Counts | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Disease Activity Score at Crohn's Disease Endpoint | Weeks 1, 2, 4, 8, and 12 | |
| Primary | Exploratory Endpoint - Change From Baseline in Psoriasis Area and Severity Index at Psoriasis Endpoint | Weeks 1, 2, 4, 8, and 12 | |
| 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. | |
| 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. | |
| Other | 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 | Planned safety evaluations included clinical laboratory tests (chemistry, hematology, and urinalysis), vital signs (blood pressure, pulse, respiratory rate, and oral temperature), physical examination (assessment of general appearance, skin, head \[eyes, ears, nose and throat\], neck, thyroid, lungs, heart, abdomen, back, lymph nodes, and extremities, and body weight), 12-lead electrocardiograms, adverse event reporting, concomitant medication, and lymphocyte counts. |
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.
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GET https://conductscience.org/api/trials/v1/NCT03139032/registered