Trial Outcomes & Findings for Beryllium Infliximab Study: Clinical Interventional Trial (NCT NCT00111917)

Results Overview

change in end-exercise A-a gradient

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen

Results posted on

2016-06-02

Participant Flow

We aimed to enroll 20 CBD subjects on stable doses of corticosteroids and/or methotrexate, with no evidence of active or chronic infection, malignancy, other chronic disease, or past treatment with another biologic with a 3:1 infliximab:placebo ratio

the sponsor stopped the study due to slow recruitment

Participant milestones

Participant milestones
Measure	Group 1 - Infliximab This group was given an infusion of inliximab	Group 2 - Placebo This group was given a placebo infusion
Overall Study STARTED	9	4
Overall Study COMPLETED	8	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 - Infliximab This group was given an infusion of inliximab	Group 2 - Placebo This group was given a placebo infusion
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Beryllium Infliximab Study: Clinical Interventional Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab n=9 Participants patients who will be placed on infliximab and controls who will get placebo	Control n=4 Participants CBD placed on placebo	Total n=13 Participants Total of all reporting groups
Age, Continuous	54.63 years n=5 Participants	69.75 years n=7 Participants	56.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen

Population: Accurate measures were not obtained on all patients at both timepoints.

change in end-exercise A-a gradient

Outcome measures

Outcome measures
Measure	Infliximab n=7 Participants Infliximab infusion	Placebo n=2 Participants Placebo infusion
A-a Gradient at End Exercise	27.3 mmHg Standard Error 10.56	94.17 mmHg Standard Error 18.73

POST_HOC outcome

Timeframe: after 28 week follow-up

Absolute number of lymphocytes\*10\^6/cc in blood

Outcome measures

Outcome measures
Measure	Infliximab n=8 Participants Infliximab infusion	Placebo n=2 Participants Placebo infusion
Absolute Numbers of Lymphocytes	1.7 absolute number*10^6/cc Standard Error 0.18	1.02 absolute number*10^6/cc Standard Error 0.56

POST_HOC outcome

Timeframe: after 28 weeks

WBC \* 10\^6/cc in bronchalveolar lavage

Outcome measures

Outcome measures
Measure	Infliximab n=5 Participants Infliximab infusion	Placebo n=2 Participants Placebo infusion
BAL WBC/cc	0.23 absolute WBC*10^6/cc Standard Deviation 0.04	0.25 absolute WBC*10^6/cc Standard Deviation 0.03

POST_HOC outcome

Timeframe: after 28 week infusion

% of WBCs that are lymphocytes in bronchoalveolar lavage

Outcome measures

Outcome measures
Measure	Infliximab n=5 Participants Infliximab infusion	Placebo n=2 Participants Placebo infusion
BAL % Lymphocytes	4.68 percentage of lymphocytes in BAL Standard Deviation 7.84	14.7 percentage of lymphocytes in BAL Standard Deviation 0

Adverse Events

Group 1 - Infliximab

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 - Infliximab n=8 participants at risk Infliximab infusion received	Group 2 - Placebo n=3 participants at risk Placebo infusion received
Hepatobiliary disorders Acute cholecystitis	12.5% 1/8 • Number of events 1 • through week 40 adverse events reported through week 40	0.00% 0/3 • through week 40 adverse events reported through week 40
Gastrointestinal disorders Nausea, vomiting	12.5% 1/8 • Number of events 1 • through week 40 adverse events reported through week 40	0.00% 0/3 • through week 40 adverse events reported through week 40
Hepatobiliary disorders liver function levels	12.5% 1/8 • Number of events 1 • through week 40 adverse events reported through week 40	0.00% 0/3 • through week 40 adverse events reported through week 40
Renal and urinary disorders Kidney stone	0.00% 0/8 • through week 40 adverse events reported through week 40	33.3% 1/3 • Number of events 1 • through week 40 adverse events reported through week 40

Other adverse events

Adverse event data not reported

Additional Information

Lisa Maier, MD

National Jewish Health

Phone: 303-398-1983

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place