A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
- Conditions
- Crohn Disease
- Interventions
- Biological: Cimzia
- Registration Number
- NCT00552344
- Lead Sponsor
- UCB BIOSCIENCES GmbH
- Brief Summary
The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 \[NCT00552058\].
- Detailed Description
This study consisted of:
* Induction Period (dosing at Weeks 0, 2, and 4)
* Maintenance Dosing (dosing every 4 weeks up to Week 260)
* End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- Subject participated in study C87085 [NCT00552058] in which the subject completed the study at Week 6
- Subject is capable of providing informed consent, which must be obtained prior to any study related procedures
- Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or pulmonary physician, with no evidence of current active Tuberculosis (TB) or old inactive TB
- Subject has taken a TB survey and is committed to comply with TB prophylaxis if applicable
- Subject is experiencing an ongoing serious adverse event assessed as being related to study medication or is experiencing a serious adverse event that is still not assessable
- Subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)
- Subject is non-compliant with TB prophylactic treatment (if applicable)
- Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a malignancy or active infection, including TB
- Female who is pregnant or breast feeding
- Female of child bearing age or post puberty males not practicing effective birth control
- Subject is expecting to receive any live virus or bacterial vaccination within 3 months of first Study Medication administration, during the trial or 3 months after last dose of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Certolizumab Pegol Cimzia Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks) From study start to the end of the Safety Follow-up Period (up to 272 weeks) An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks) From study start to the end of the Safety Follow-up Period (up to 272 weeks) An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52) Week 52 Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088 From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks) Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 \[NCT00552058\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262) Week 262 HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262) Week 262 IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
Trial Locations
- Locations (100)
284
🇺🇸Lakewood, Colorado, United States
278
🇺🇸New Port Richey, Florida, United States
279
🇺🇸Louisville, Kentucky, United States
300
🇺🇸Winter Park, Florida, United States
276
🇺🇸Chicago, Illinois, United States
272
🇺🇸Raleigh, North Carolina, United States
310
🇺🇸Chesterfield, Michigan, United States
296
🇺🇸Cincinnati, Ohio, United States
280
🇺🇸Lancaster, Pennsylvania, United States
308
🇺🇸Norfolk, Virginia, United States
290
🇺🇸Seattle, Washington, United States
15
🇦🇺Concord, New South Wales, Australia
20
🇦🇺Box Hill, Victoria, Australia
11
🇦🇺Fitzroy, Australia
14
🇦🇺Bankstown, Australia
18
🇦🇺Garran, Australia
13
🇦🇺Fremantle, Australia
31
🇧🇪Gent, Belgium
35
🇧🇪Leuven, Belgium
52
🇧🇷Porto Alegre, RS, Brazil
41
🇧🇷Curitiba, Brazil
53
🇧🇷Santos, Brazil
55
🇧🇷Sao Paulo, Brazil
60
🇨🇦Winnepeg, Manitoba, Canada
62
🇨🇦Kingston, Ontario, Canada
95
🇨🇿Hradec Kralove, Czechia
98
🇨🇿Praha 7, Czechia
97
🇨🇿Hradek Kralove, Czechia
100
🇪🇪Tallin, Estonia
152
🇭🇺Szombathely, Hungary
164
🇮🇱Haifa, Israel
167
🇮🇱Holon, Israel
163
🇮🇱Kfar Saba, Israel
166
🇮🇱Petha Tikva, Israel
169
🇮🇱Zerifin, Israel
176
🇮🇹Padova, Italy
171
🇮🇹Roma, Italy
174
🇮🇹Roma, Italy
289
🇺🇸Cleveland, Ohio, United States
212
🇵🇱Warszawa, Poland
210
🇵🇱Lodz, Poland
221
🇷🇴Cluj Napoca, Romania
213
🇵🇱Wroclaw, Poland
225
🇷🇴Constanta, Romania
230
🇷🇺Moscow, Russian Federation
234
🇷🇺Moscow, Russian Federation
251
🇺🇦Donetsk, Ukraine
256
🇺🇦Kiev, Ukraine
257
🇺🇦Lviv, Ukraine
275
🇺🇸Metairie, Louisiana, United States
281
🇺🇸Annapolis, Maryland, United States
295
🇺🇸Towson, Maryland, United States
307
🇺🇸Monroe, Louisiana, United States
32
🇧🇪Bonheiden, Belgium
30
🇧🇪Roeselare, Belgium
64
🇨🇦Edmonton, Alberta, Canada
305
🇺🇸Germantown, Tennessee, United States
306
🇺🇸Germantown, Tennessee, United States
16
🇦🇺Parkville, Victoria, Australia
12
🇦🇺Footscray, Victoria, Australia
270
🇦🇹Wien, Austria
34
🇧🇪Liege, Belgium
45
🇧🇷Belo-Horizonte, Brazil
51
🇧🇷Rio de Janeiro, Brazil
70
🇨🇦London, Ontario, Canada
101
🇪🇪Tartu, Estonia
151
🇭🇺Budapest, Hungary
140
🇩🇪Homburg, Germany
130
🇩🇪Wilhelmshaven, Germany
66
🇨🇦Toronto, Ontario, Canada
68
🇨🇦Toronto, Ontario, Canada
67
🇨🇦Hamilton, Ontario, Canada
63
🇨🇦London, Ontario, Canada
137
🇩🇪Kiel, Germany
153
🇭🇺Szeged, Hungary
144
🇩🇪Ulm, Germany
155
🇭🇺Budapest, Hungary
161
🇮🇱Beer Sheva, Israel
156
🇭🇺Budapest, Hungary
154
🇭🇺Gyor, Hungary
150
🇭🇺Nagykanizsa, Hungary
192
🇱🇻Riga, Latvia
193
🇱🇻Riga, Latvia
217
🇵🇱Czestochowa, Poland
232
🇷🇺Kazan, Russian Federation
259
🇺🇦Kiev, Ukraine
254
🇺🇦Simferopol, Ukraine
160
🇮🇱Tel Aviv, Israel
191
🇱🇻Riga, Latvia
202
🇳🇿Milford, Auckland, New Zealand
200
🇳🇿Christchurch, New Zealand
203
🇳🇿Hamilton, New Zealand
204
🇳🇿Newton, Wellington, New Zealand
218
🇵🇱Czestochowa, Poland
201
🇳🇿Auckland, New Zealand
258
🇺🇦Dniepropetrovsk, Ukraine
211
🇵🇱Warszawa, Poland
233
🇷🇺St Petersburg, Russian Federation
285
🇺🇸Littleton, Colorado, United States
298
🇺🇸Rochester, Minnesota, United States