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Trial of Adalimumab in Progressive Sarcoidosis

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ClinicalTrials.gov Identifier: NCT00311246
Recruitment Status : Terminated (Difficulty in recruiting subjects)
First Posted : April 5, 2006
Results First Posted : August 14, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoidosis
Intervention Drug: Adalimumab
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title An Open-label
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Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title An Open-label
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Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
The population is male and female between the ages of 18-65
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
[1]
Measure Description: YEARS IS A CATEGORICAL VARIABLE
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
10
  90.9%
Male
1
   9.1%
[1]
Measure Description: THE UNIT OF MEASURE IS FEMALE, MALE
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Change in FVC From Screening to Week 24
Hide Description 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.
Time Frame 24 Weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title An Open-label
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Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Liters
Participant 1 -1
Participant 2 -3
Participant 3 6
Participant 4 -1
Participant 5 -1
Participant 6 4
Participant 7 13
Participant 8 5
Participant 9 5
Participant 10 3
Participant 11 -1
2.Secondary Outcome
Title Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks
Hide Description This is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes
Time Frame 24 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title An Open-label
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Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Meters
Participant 1 124
Participant 2 -92
Participant 3 20
Participant 4 109
Participant 5 -34
Participant 6 288
Participant 7 124
Participant 8 -113
Participant 9 -44
Participant 10 113
Participant 11 -90
3.Secondary Outcome
Title A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W).
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Borg Dyspnea Scores
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This scale was used to measure a patients breathlessness before/after the 6 Minute Walk at Screening and at 24 weeks.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Units on a scale
Participant 1 3
Participant 2 3
Participant 3 1
Participant 4 3
Participant 5 4
Participant 6 0
Participant 7 7.5
Participant 8 2
Participant 9 1.5
Participant 10 0
Participant 11 1
4.Secondary Outcome
Title Physicians Global Assessment of Disease Activity.
Hide Description 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.
Time Frame 24 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physicians Global Assessment
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[Not Specified]
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
81  (12)
5.Secondary Outcome
Title Patient's Global Assessment of Disease Activity.
Hide Description 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.
Time Frame 24 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Global Assessment
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[Not Specified]
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: score on a scale
54  (5)
Time Frame Adverse events were collected from week zero till week 52
Adverse Event Reporting Description no serious adverse events
 
Arm/Group Title An Open-label
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Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

Adalimumab: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

There were no adverse events.

All-Cause Mortality
An Open-label
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
An Open-label
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
An Open-label
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nadera J Sweiss
Organization: UIC
Phone: 312-996-5723
EMail: nsweiss@uic.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00311246    
Other Study ID Numbers: University of Chicago #14093A
First Submitted: April 3, 2006
First Posted: April 5, 2006
Results First Submitted: September 18, 2015
Results First Posted: August 14, 2020
Last Update Posted: August 25, 2020