Trial Outcomes & Findings for Trial of Adalimumab in Progressive Sarcoidosis (NCT NCT00311246)

NCT ID: NCT00311246

Last Updated: 2020-08-25

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2020-08-25

Participant Flow

Participant milestones

Measure	An Open-label 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 Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Adalimumab in Progressive Sarcoidosis

Baseline characteristics by cohort

Measure	An Open-label n=11 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	An Open-label n=11 Participants 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.
Change in FVC From Screening to Week 24 Participant 1	-1 Liters
Change in FVC From Screening to Week 24 Participant 2	-3 Liters
Change in FVC From Screening to Week 24 Participant 3	6 Liters
Change in FVC From Screening to Week 24 Participant 4	-1 Liters
Change in FVC From Screening to Week 24 Participant 5	-1 Liters
Change in FVC From Screening to Week 24 Participant 6	4 Liters
Change in FVC From Screening to Week 24 Participant 7	13 Liters
Change in FVC From Screening to Week 24 Participant 8	5 Liters
Change in FVC From Screening to Week 24 Participant 9	5 Liters
Change in FVC From Screening to Week 24 Participant 10	3 Liters
Change in FVC From Screening to Week 24 Participant 11	-1 Liters

SECONDARY outcome

Timeframe: 24 weeks

This is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes

Outcome measures

Measure	An Open-label n=11 Participants 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.
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 3	20 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 1	124 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 2	-92 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 4	109 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 5	-34 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 6	288 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 7	124 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 8	-113 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 9	-44 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 10	113 Meters
Change in Distance Walked During 6 Minute Walk Test at Screening and 24 Weeks Participant 11	-90 Meters

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	An Open-label n=11 Participants 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.
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 1	3 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 2	3 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 3	1 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 4	3 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 5	4 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 6	0 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 7	7.5 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 8	2 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 9	1.5 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 10	0 Units on a scale
A Change in the Borg Dyspnea Score Before/After the 6 Minute Walk at Screening (S) and at 24 Weeks (W). Participant 11	1 Units on a scale

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	An Open-label n=11 Participants 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.
Physicians Global Assessment of Disease Activity.	81 units on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	An Open-label n=11 Participants 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.
Patient's Global Assessment of Disease Activity.	54 score on a scale Standard Deviation 5

Adverse Events

An Open-label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nadera J Sweiss

UIC

Phone: 312-996-5723

Email: nsweiss@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place