A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

Crohn Disease Clinical Trial

Official title:

A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552344
• Other study ID #: C87088
• Secondary ID: 2007-002716-26
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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 information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• Cimzia
Active substance: Certolizumab Pegol Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous use

Locations

Country	Name	City	State
Australia	14	Bankstown
Australia	20	Box Hill	Victoria
Australia	15	Concord	New South Wales
Australia	11	Fitzroy
Australia	12	Footscray	Victoria
Australia	13	Fremantle
Australia	18	Garran
Australia	16	Parkville	Victoria
Austria	270	Wien
Belgium	32	Bonheiden
Belgium	31	Gent
Belgium	35	Leuven
Belgium	34	Liege
Belgium	30	Roeselare
Brazil	45	Belo-Horizonte
Brazil	41	Curitiba
Brazil	52	Porto Alegre	RS
Brazil	51	Rio de Janeiro
Brazil	53	Santos
Brazil	55	Sao Paulo
Canada	64	Edmonton	Alberta
Canada	67	Hamilton	Ontario
Canada	62	Kingston	Ontario
Canada	63	London	Ontario
Canada	70	London	Ontario
Canada	66	Toronto	Ontario
Canada	68	Toronto	Ontario
Canada	60	Winnepeg	Manitoba
Czechia	95	Hradec Kralove
Czechia	97	Hradek Kralove
Czechia	98	Praha 7
Estonia	100	Tallin
Estonia	101	Tartu
Germany	140	Homburg
Germany	137	Kiel
Germany	144	Ulm
Germany	130	Wilhelmshaven
Hungary	151	Budapest
Hungary	155	Budapest
Hungary	156	Budapest
Hungary	154	Gyor
Hungary	150	Nagykanizsa
Hungary	153	Szeged
Hungary	152	Szombathely
Israel	161	Beer Sheva
Israel	164	Haifa
Israel	167	Holon
Israel	163	Kfar Saba
Israel	166	Petha Tikva
Israel	160	Tel Aviv
Israel	169	Zerifin
Italy	176	Padova
Italy	171	Roma
Italy	174	Roma
Latvia	191	Riga
Latvia	192	Riga
Latvia	193	Riga
New Zealand	201	Auckland
New Zealand	200	Christchurch
New Zealand	203	Hamilton
New Zealand	202	Milford	Auckland
New Zealand	204	Newton	Wellington
Poland	217	Czestochowa
Poland	218	Czestochowa
Poland	210	Lodz
Poland	211	Warszawa
Poland	212	Warszawa
Poland	213	Wroclaw
Romania	221	Cluj Napoca
Romania	225	Constanta
Russian Federation	232	Kazan
Russian Federation	230	Moscow
Russian Federation	234	Moscow
Russian Federation	233	St Petersburg
Ukraine	258	Dniepropetrovsk
Ukraine	251	Donetsk
Ukraine	256	Kiev
Ukraine	259	Kiev
Ukraine	257	Lviv
Ukraine	254	Simferopol
United States	281	Annapolis	Maryland
United States	310	Chesterfield	Michigan
United States	276	Chicago	Illinois
United States	296	Cincinnati	Ohio
United States	289	Cleveland	Ohio
United States	305	Germantown	Tennessee
United States	306	Germantown	Tennessee
United States	284	Lakewood	Colorado
United States	280	Lancaster	Pennsylvania
United States	285	Littleton	Colorado
United States	279	Louisville	Kentucky
United States	275	Metairie	Louisiana
United States	307	Monroe	Louisiana
United States	278	New Port Richey	Florida
United States	308	Norfolk	Virginia
United States	272	Raleigh	North Carolina
United States	298	Rochester	Minnesota
United States	290	Seattle	Washington
United States	295	Towson	Maryland
United States	300	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
UCB BIOSCIENCES GmbH	PPD

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czechia,  Estonia,  Germany,  Hungary,  Israel,  Italy,  Latvia,  New Zealand,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (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.	From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Primary	Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (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.	From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Secondary	Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI = 4) at Study Completion Visit (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.	Week 262
Secondary	Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ = 170) at Study Completion Visit (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.	Week 262
Secondary	Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)	Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.	Week 52
Secondary	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	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.	From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)