Trial · NCT03793439
Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis
NCT03793439, Phase 1, Completed, Oregon Health and Science University; results first posted 2022-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis. Trials, record NCT03793439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03793439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis
- NCT number
- NCT03793439
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Sarcoidosis, Pulmonary, Sarcoidosis Lung, Sarcoidosis
- Interventions
- Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial, Spirometry, RNA Sequencing, Laboratory testing, Corticosteroid, Tofacitinib 5mg [Xeljanz] 1 year open-label extension
- First posted
- 2019-01-04
- Last updated
- 2022-02-18
- Results first posted
- 2022-02-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With 50% Reduction in Corticosteroid Requirement | 16 weeks | 50% reduction in corticosteroid requirement by week 16, without significant decline in their pulmonary function-defined as a \>15% decline in forced vital capacity (FVC), forced expiratory volume at 1 second (FEV1), or diffusing capacity of lung for carbon monoxide (DLCO) relative to the baseline value |
| Secondary | Number of Participants With Significantly Decreased Expression of STAT1 Mediated Genes as Determined by RNA Sequencing | 16 weeks | Peripheral blood RNA sequencing performed before and after 16 weeks of tofacitinib treatment. Significant changes are defined as at least 1.5 fold change in the expression of STAT1-mediated genes, with a false discover rate p value of \< 0.05. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With 50% Reduction in Corticosteroid Requirement | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Significantly Decreased Expression of STAT1 Mediated Genes as Determined by RNA Sequencing | 16 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With 50% Reduction in Corticosteroid Requirement | Open Label | 3 | Participants | ||
| Number of Participants With Significantly Decreased Expression of STAT1 Mediated Genes as Determined by RNA Sequencing | Open Label | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label | 5 | |
| Overall Study | COMPLETED | Open Label | 3 | |
| Overall Study | NOT COMPLETED | Open Label | 2 |
Source ClinicalTrials.gov
Adverse events10
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 | Rash maculo-papular | Skin and subcutaneous tissue disorders | Open Label | 1 | 5 | 1 |
| other | Vomiting | Gastrointestinal disorders | Open Label | 1 | 5 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Open Label | 2 | 5 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Open Label | 1 | 5 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Open Label | 1 | 5 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Open Label | 1 | 5 | 1 |
| other | Renal colic | Renal and urinary disorders | Open Label | 1 | 5 | 1 |
| other | Bronchial infection | Respiratory, thoracic and mediastinal disorders | Open Label | 1 | 5 | 1 |
| serious | Peripheral motor neuropathy | Nervous system disorders | Open Label | 1 | 5 | 1 |
| serious | Skin infection | Skin and subcutaneous tissue disorders | Open Label | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label | 0 | 5 |
| Total, other adverse events | Open Label | 4 | 5 |
| Total, serious adverse events | Open Label | 2 | 5 |
Source ClinicalTrials.gov
Papers2
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/NCT03793439
GET https://conductscience.org/api/trials/v1/NCT03793439/registered