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Trial record 5 of 158 for:    interstitial cystitis

Efficacy Study of Adalimumab to Treat Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT01295814
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Philip C. Bosch, M.D., ICStudy, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Interventions Drug: Adalimumab
Other: inactive drug
Enrollment 43
Recruitment Details subject were recruited from medical practices and by advertisement starting March 2011 through January 2013.
Pre-assignment Details A total of 4 subjects did not meet screening criteria.
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description inactive drug : placebo Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Period Title: Overall Study
Started 22 21
Completed 20 19
Not Completed 2 2
Reason Not Completed
Lack of Efficacy             0             2
Withdrawal by Subject             2             0
Arm/Group Title Inactive Drug Adalimumab Total
Hide Arm/Group Description inactive drug : placebo Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
21
 100.0%
43
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
46.5  (13.4) 45.2  (14) 45.9  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
18
  81.8%
16
  76.2%
34
  79.1%
Male
4
  18.2%
5
  23.8%
9
  20.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 43 participants
22 21 43
1.Primary Outcome
Title O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score
Hide Description 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)
Time Frame Baseline/12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description:
inactive drug : placebo
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.7  (4.9) 27.8  (3.9)
Week 12 19.6  (10.7) 19.9  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inactive Drug, Adalimumab
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Type of Statistical Test Non-Inferiority or Equivalence
Comments

The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.

The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12.

Statistical Test of Hypothesis P-Value 0.75
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
4.0 to 11.8
Estimation Comments Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.
2.Secondary Outcome
Title Interstitial Cystitis Symptom Index (ICSI)
Hide Description Improvement 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)
Time Frame Baseline/ 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description:
inactive drug : placebo
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 14.2  (3.1) 14.0  (2.7)
Week 12 10.5  (5.7) 10.0  (4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inactive Drug, Adalimumab
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
1.7 to 6.3
Estimation Comments Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.
3.Secondary Outcome
Title Interstitial Cystitis Problem Index (ICPI)
Hide Description Improvement 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)
Time Frame Baseline/12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description:
inactive drug : placebo
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 13.5  (2.2) 13.8  (1.7)
Week 12 9.1  (5.1) 9.9  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inactive Drug, Adalimumab
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
2.1 to 5.8
Estimation Comments Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.
4.Secondary Outcome
Title Pelvic Pain Urgency/Frequency (PUF) Score
Hide Description Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)
Time Frame Baseline12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description:
inactive drug : placebo
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 24.2  (3.9) 24.6  (4.1)
Week 12 17.3  (8.7) 18.3  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inactive Drug, Adalimumab
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
2.6 to 10.0
Estimation Comments Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.
5.Secondary Outcome
Title Global Response Assessment (GRA)
Hide Description

Percent(%) of patients who reported 50% or greater overall improvement in their condition.

Score on a scale range (improvement 0%-100%)

Time Frame Measured at12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description:
inactive drug : placebo
Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: percentage of participants
50 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inactive Drug, Adalimumab
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description March 2011 to March 2013
 
Arm/Group Title Inactive Drug Adalimumab
Hide Arm/Group Description inactive drug : placebo Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
All-Cause Mortality
Inactive Drug Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Inactive Drug Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inactive Drug Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/22 (95.45%)      17/21 (80.95%)    
Gastrointestinal disorders     
Diarrhea *  7/22 (31.82%)  8 1/21 (4.76%)  1
Vomiting *  0/22 (0.00%)  0 3/21 (14.29%)  3
Salmonella *  0/22 (0.00%)  0 3/21 (14.29%)  3
Nausea *  3/22 (13.64%)  3 3/21 (14.29%)  3
Gastritis *  0/22 (0.00%)  0 3/21 (14.29%)  3
General disorders     
Headache *  5/22 (22.73%)  10 3/21 (14.29%)  3
Dizziness *  3/22 (13.64%)  3 0/21 (0.00%)  0
Fatigue *  5/22 (22.73%)  5 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain * [1]  8/22 (36.36%)  10 3/21 (14.29%)  3
Renal and urinary disorders     
Urinary Tract Infection   3/22 (13.64%)  3 5/21 (23.81%)  8
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection *  7/22 (31.82%)  11 12/21 (57.14%)  14
Skin and subcutaneous tissue disorders     
Rash *  2/22 (9.09%)  2 5/21 (23.81%)  5
Injection Site Reaction   0/22 (0.00%)  0 4/21 (19.05%)  10
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Does not include headache
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Philip C. Bosch, MD
Organization: IC Study, LLC
Phone: 760-743-3135
Responsible Party: Philip C. Bosch, M.D., ICStudy, LLC
ClinicalTrials.gov Identifier: NCT01295814     History of Changes
Other Study ID Numbers: IMM 10-0061
First Submitted: February 14, 2011
First Posted: February 15, 2011
Results First Submitted: July 20, 2013
Results First Posted: July 16, 2015
Last Update Posted: July 16, 2015