Trial Outcomes & Findings for Efficacy Study of Adalimumab to Treat Interstitial Cystitis (NCT NCT01295814)
NCT ID: NCT01295814
Last Updated: 2015-07-16
Results Overview
Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
Baseline/12 Weeks
Results posted on
2015-07-16
Participant Flow
subject were recruited from medical practices and by advertisement starting March 2011 through January 2013.
A total of 4 subjects did not meet screening criteria.
Participant milestones
| Measure |
Inactive Drug
inactive drug : placebo
|
Adalimumab
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Inactive Drug
inactive drug : placebo
|
Adalimumab
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Efficacy Study of Adalimumab to Treat Interstitial Cystitis
Baseline characteristics by cohort
| Measure |
Inactive Drug
n=22 Participants
inactive drug : placebo
|
Adalimumab
n=21 Participants
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 14 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline/12 WeeksImprovement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)
Outcome measures
| Measure |
Inactive Drug
n=22 Participants
inactive drug : placebo
|
Adalimumab
n=21 Participants
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score
Baseline
|
27.7 units on a scale
Standard Deviation 4.9
|
27.8 units on a scale
Standard Deviation 3.9
|
|
O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score
Week 12
|
19.6 units on a scale
Standard Deviation 10.7
|
19.9 units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline/ 12 weeksImprovement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)
Outcome measures
| Measure |
Inactive Drug
n=22 Participants
inactive drug : placebo
|
Adalimumab
n=21 Participants
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Interstitial Cystitis Symptom Index (ICSI)
Baseline
|
14.2 units on a scale
Standard Deviation 3.1
|
14.0 units on a scale
Standard Deviation 2.7
|
|
Interstitial Cystitis Symptom Index (ICSI)
Week 12
|
10.5 units on a scale
Standard Deviation 5.7
|
10.0 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline/12 WeeksImprovement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)
Outcome measures
| Measure |
Inactive Drug
n=22 Participants
inactive drug : placebo
|
Adalimumab
n=21 Participants
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Interstitial Cystitis Problem Index (ICPI)
Baseline
|
13.5 units on a scale
Standard Deviation 2.2
|
13.8 units on a scale
Standard Deviation 1.7
|
|
Interstitial Cystitis Problem Index (ICPI)
Week 12
|
9.1 units on a scale
Standard Deviation 5.1
|
9.9 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline12 WeeksPelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)
Outcome measures
| Measure |
Inactive Drug
n=22 Participants
inactive drug : placebo
|
Adalimumab
n=21 Participants
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Pelvic Pain Urgency/Frequency (PUF) Score
Week 12
|
17.3 units on a scale
Standard Deviation 8.7
|
18.3 units on a scale
Standard Deviation 6.9
|
|
Pelvic Pain Urgency/Frequency (PUF) Score
Baseline
|
24.2 units on a scale
Standard Deviation 3.9
|
24.6 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Measured at12 WeeksPercent(%) of patients who reported 50% or greater overall improvement in their condition. Score on a scale range (improvement 0%-100%)
Outcome measures
| Measure |
Inactive Drug
n=22 Participants
inactive drug : placebo
|
Adalimumab
n=21 Participants
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Global Response Assessment (GRA)
|
50 percentage of participants
|
53 percentage of participants
|
Adverse Events
Inactive Drug
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Adalimumab
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inactive Drug
n=22 participants at risk
inactive drug : placebo
|
Adalimumab
n=21 participants at risk
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
31.8%
7/22 • Number of events 8 • 2 years
March 2011 to March 2013
|
4.8%
1/21 • Number of events 1 • 2 years
March 2011 to March 2013
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
2/22 • Number of events 2 • 2 years
March 2011 to March 2013
|
23.8%
5/21 • Number of events 5 • 2 years
March 2011 to March 2013
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.00%
0/22 • 2 years
March 2011 to March 2013
|
19.0%
4/21 • Number of events 10 • 2 years
March 2011 to March 2013
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
31.8%
7/22 • Number of events 11 • 2 years
March 2011 to March 2013
|
57.1%
12/21 • Number of events 14 • 2 years
March 2011 to March 2013
|
|
Musculoskeletal and connective tissue disorders
Pain
|
36.4%
8/22 • Number of events 10 • 2 years
March 2011 to March 2013
|
14.3%
3/21 • Number of events 3 • 2 years
March 2011 to March 2013
|
|
General disorders
Headache
|
22.7%
5/22 • Number of events 10 • 2 years
March 2011 to March 2013
|
14.3%
3/21 • Number of events 3 • 2 years
March 2011 to March 2013
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • 2 years
March 2011 to March 2013
|
14.3%
3/21 • Number of events 3 • 2 years
March 2011 to March 2013
|
|
Renal and urinary disorders
Urinary Tract Infection
|
13.6%
3/22 • Number of events 3 • 2 years
March 2011 to March 2013
|
23.8%
5/21 • Number of events 8 • 2 years
March 2011 to March 2013
|
|
Gastrointestinal disorders
Salmonella
|
0.00%
0/22 • 2 years
March 2011 to March 2013
|
14.3%
3/21 • Number of events 3 • 2 years
March 2011 to March 2013
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Number of events 3 • 2 years
March 2011 to March 2013
|
14.3%
3/21 • Number of events 3 • 2 years
March 2011 to March 2013
|
|
General disorders
Dizziness
|
13.6%
3/22 • Number of events 3 • 2 years
March 2011 to March 2013
|
0.00%
0/21 • 2 years
March 2011 to March 2013
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/22 • 2 years
March 2011 to March 2013
|
14.3%
3/21 • Number of events 3 • 2 years
March 2011 to March 2013
|
|
General disorders
Fatigue
|
22.7%
5/22 • Number of events 5 • 2 years
March 2011 to March 2013
|
0.00%
0/21 • 2 years
March 2011 to March 2013
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER