Trial · NCT00311246
Trial of Adalimumab in Progressive Sarcoidosis
NCT00311246, Phase 2, Terminated, University of Chicago; results first posted 2020-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Adalimumab in Progressive Sarcoidosis. Trials, record NCT00311246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00311246
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Adalimumab in Progressive Sarcoidosis
- NCT number
- NCT00311246
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Sarcoidosis
- Interventions
- Adalimumab
- First posted
- 2006-04-05
- Last updated
- 2020-08-25
- Results first posted
- 2020-08-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in FVC From Screening to Week 24 | 24 Weeks | The forced vital capacity (FVC) measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath. Improvement in FVC, if significant, means better breathing and lung function. The change in FVC done at screening and at week 24 were compared to notice if there were any changes. |
| Secondary | Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks | 24 weeks | This is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes |
| Secondary | A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). | 24 weeks | This scale was used to measure a patients breathlessness before/after the 6 Minute Walk. This score was used at Screening (S) and at 24 weeks (W). The borg scale ranges from zero to 10 with zero being no breathlessness at all and 10 being maximal breathlessness. A change between screening and week 24 is reported. |
| Secondary | Physicians Global Assessment of Disease Activity. | 24 weeks | This assessment to determine the level of disease activity. Scores range from 0 (no pulmonary manifestations of sarcoidosis) to 100 (worsening of pulmonary symptoms) on a visual analog scale. |
| Secondary | Patient's Global Assessment of Disease Activity. | 24 weeks | This is the patients measurement of disease activity. Scores range from 0 (no pulmonary manifestations of sarcoidosis) to 100 (worsening of pulmonary symptoms) on a visual analog scale. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in FVC From Screening to Week 24 | 24 Weeks | Liters | NUMBER | |
| SECONDARY | Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks | 24 weeks | Meters | NUMBER | |
| SECONDARY | A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). | 24 weeks | Units on a scale | NUMBER | |
| SECONDARY | Physicians Global Assessment of Disease Activity. | 24 weeks | units on a scale | MEAN | |
| SECONDARY | Patient's Global Assessment of Disease Activity. | 24 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in FVC From Screening to Week 24 | An Open-label | Participant 1 | -1 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 2 | -3 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 3 | 6 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 4 | -1 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 5 | -1 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 6 | 4 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 7 | 13 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 8 | 5 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 9 | 5 | Liters | |
| Change in FVC From Screening to Week 24 | An Open-label | Participant 10 | 3 | Liters |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | An Open-label | 11 | |
| Overall Study | COMPLETED | An Open-label | 11 | |
| Overall Study | NOT COMPLETED | An Open-label | 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 | An Open-label | ||
| Total, other adverse events | An Open-label | 0 | 11 |
| Total, serious adverse events | An Open-label | 0 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24751453 | DERIVED |
Source PubMed
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/NCT00311246
GET https://conductscience.org/api/trials/v1/NCT00311246/results?page=2