Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8

Placebo: given subcutaneously at week 0, 2, 4, and week 8

Experimental drug certolizumab pegol 400mg.

Certolizumab Pegol

Placebo

Total

Only females between the age of 18 to 65.

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Subjects rated the presence and extent of IC/BPS symptoms by completing the O'Leary-Sant Interstitial Cystitis Symptom Index and the O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) at baseline and at weeks 2, 4, 10, and 18. Lubeck et al validated ICSI as a valid measure of change in treatment outcome studies. Propert et al validated the ICSI as responsive to change in IC/BPS symptoms and was recommended as secondary endpoints in clinical trials. No urinary symptoms would have a score of 0. The most severe symptoms would be a maximum of 35. Normal patients have a value of 7 or less.

O'Leary Sant Symptom and Problem Index

Patient-reported global response assessment (GRA) such as "Compared to when you began this trial, how would you rate your IC symptoms now?" Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved.

Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8
Certolizumab pegol: 400 mg

Group 1: Experimental

Placebo: given subcutaneously at week 0, 2, 4, and week 8
Placebo: Normal saline

Group 2: Placebo Comparator

IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)

The Interstitial Cystitis Symptom Index is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 19 with severe symptoms. Lubeck et al. validated ICSI as a valid measure of change in treatment outcome studies. A change of -4.03 in the ICSI score was the same as a 2 point improvement in GRA. Propert et al. validated the ICSI as responsive to change in IC/BPS symptoms and was recommended as secondary endpoints in clinical trials. A change of -2.4 in the ICSI score was the same as a 2 point improvement in GRA.

IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index

The Interstitial Cystitis Symptom Index (ICPI) is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 16 with severe symptoms.

IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)

an 11-point pain intensity numerical rating scale. Subjects rated their average pain, pressure, or discomfort associated with their bladder using an 11-point pain intensity numerical rating scale of 0-no pain to 10-worse ever pain at baseline, and at weeks 2, 4, 10, and 18. Meaningful, clinically important pain relief is a reduction in pain of approximately 30% from baseline.

Pain Scale

Subjects rated their average urinary urgency or need to urinate using an 11-point numerical rating scale of 0-no urgency to 10-worse ever urgency

Urgency Scale

Overall Study

Philip C. Bosch, MD

Cystitis, Interstitial

Certolizumab pegol

Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Philip C. Bosch, M.D.

Philip C Bosch, MD

ICStudy, LLC

UCB Pharma

Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks

Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks

Inactive Drug

Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

Adalimumab

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)

O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score

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)

Interstitial Cystitis Symptom Index (ICSI)

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)

Interstitial Cystitis Problem Index (ICPI)

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)

Pelvic Pain Urgency/Frequency (PUF) Score

Percent(%) of patients who reported 50% or greater overall improvement in their condition.
Score on a scale range (improvement 0%-100%)

Global Response Assessment (GRA)

Interstitial Cystitis

80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

inactive drug

Efficacy Study of Adalimumab to Treat Interstitial Cystitis

An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)

nocturia/nekroz

Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Efficacy Study of Adalimumab to Treat Interstitial Cystitis

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