Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— CONNECT-IBD  

Official title:

POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539368
• Other study ID #: ZOB INF 1402
• Secondary ID: C1231001
• Status: Completed
• Start date: April 22, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: January 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:

• To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade

• To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

• To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

Description:

The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2565
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.

2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.

Exclusion Criteria:

1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.

2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.

3. Prior history of failure to respond to Remicade or CT-P13.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Drug:
• CT-P13
biosimilar infliximab
• Remicade
infliximab

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Leuven Campus Gasthuisberg	Leuven	Vlaams Brabant
Czechia	Fakultni Nemocnice Hradec Kralove	Hradec Kralove
Czechia	Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o	Hradec Kralove
Czechia	Centrum péce o zažívací trakt, Vítkovická nemocnice	Ostrava - Vitkovice
Czechia	IKEM (Institut Klinické a Experimentální Medicíny)	Prague
Czechia	Nemocnice Na Bulovce	Praha 8 Liben
Finland	Keski-Suomen keskussairaala	Jyvaskyla
Finland	Oulu University Hospital	Oulu
Finland	Turku University Hospital	Turku
France	CHU Amiens	Amiens
France	CHU Angers	Angers
France	CHRU de Besancon	Besancon
France	Centre Hospitalier Universitaire	Caen
France	Clinique de Bercy	Charenton
France	CHU Clermontferrand	Clermont-ferrand
France	Hopital Beaujon	Clichy
France	Hôpital Louis Mourier	Colombes
France	CHU de Grenoble	Grenoble
France	CHRU	Lille
France	Hopital Edouard Herriot Pav H	Lyon
France	Hopital Europeen	Marseille
France	Hopital Nord	Marseille
France	CHU	Montpellier
France	CHU Nimes	Nimes
France	Hopital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie	Paris
France	Hopital St Louis	Paris
France	Institut Montsouris	Paris
France	CHU Lyon Sud	Pierre-Bénite
France	Hopital Metz Tessy	Pringy
France	Hopital Robert Debre	Reims
France	Chu Ch.Nicolle	Rouen
France	Service: CHU saint-etienne	Saint Priez En Jarez
France	Centre Hospitalier Universitaire	Strasbourg
France	CHU Rangueil	Toulouse
France	Hopital Purpan	Toulouse
France	CHU Nancy	Vandoeuvre les Nancy
France	Groupe hospitalier mutualiste les portes du Sud	Venissieux
Germany	Gemeinschaftspraxis im MEDICUM	Altenholz
Germany	Gastroenterologische Praxis Dr. med. B. Adami	Alzey
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	Gastroenterologie Am Bayerischen Platz	Berlin
Germany	Kreiskliniken Altotting-Burghausen	Burghausen
Germany	Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main	Frankfurt am Main
Germany	Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner	Friedrichsthal
Germany	PraxisZentrum fuer Gastroenterologie	Grevenbroich
Germany	Hamburgisches Forschungsinstitut fur chronisch entzuendliche	Hamburg
Germany	Gastroenterologische Gemeinschaftspraxis Herne	Herne
Germany	Internisten am Markt Dres. Schwerdtfeger & Lehmann	Koethen
Germany	Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen	Leipzig
Germany	Onco Studies an der Onkologie Dreiländereck	Lörrach
Germany	St. Marienkrankenhaus	Ludwigshafen am Rhein	Gartenstadt
Germany	Magen-Darm Praxis Prof. Dr. Krammer & Kollegen	Mannheim
Germany	Universitaetsmedizin Mannheim	Mannheim
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	Praxis Prof.Dr. med. Herbert Kellner	Muenchen-Nymphenburg
Germany	Gastroenterologische Gemeinschaftspraxis am Germania-Campus	Muenster
Germany	Medizinisches Versorgungszentrum Portal 10	Muenster
Germany	Praxiszentrum Alte Maelzerei	Regensburg
Germany	Magen-Darm-Zentrum Remscheid	Remscheid
Germany	Zentrum für Gastroenterologie Saarbrücken MVZ GmbH	Saarbrücken
Germany	Ambulanzzentrum-Schweinfurt	Schweinfurt
Germany	Gastroenterologische Schwerpunktpraxis Stuttgart	Stuttgart
Greece	Evangelismos Hospital	Athens
Greece	Hippokration General Hospital of Athens	Athens	Attiki
Greece	Venizeleio Hospital of Heraklion	Heraklion	Crete
Greece	University Hospital of Ioannina	Ioannina
Greece	University Hospital of Larissa	Larissa
Greece	University Hospital of Patras	Rio, Patra	Achaia
Greece	General Hospital of Thessaloniki Ippokrateio	Thessaloniki
Hungary	MH Egeszsegugyi Kozpont - Honvedkorhaz	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Szte szent-gyorgyi albert klinikai kozpont	Szeged
Italy	Fondazione Poliambulanza - Istituto Ospedaliero	Brescia
Italy	Azienda Ospedaliera per l'Emergenza Cannizzaro	Catania
Italy	Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"	Catania
Italy	Università degli Studi "G. d'Annunzio" Chieti - Pescara	Chieti
Italy	ASL 11 Empoli - Ospedale San Giuseppe	Empoli	FI
Italy	ASUR Area Vasta n. 4 - Ospedale A. Murri	Fermo
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze	FI
Italy	Università degli Studi di Genova	Genova
Italy	Ospedale Generale Provinciale di Macerata	Macerata
Italy	A.O.U. Policlinico "G.Martino"	Messina
Italy	Azienda Ospedaliera - Universitaria di Modena Policlinico	Modena
Italy	Ospedale "Sacro Cuore - Don Calabria"	Negrar	Verona
Italy	Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello	Palermo
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	PR
Italy	AOUP - Ospedale di Cisanello	Pisa
Italy	Azienda Ospedaliera Universitaria di PISA	Pisa
Italy	Ospedale Sandro Pertini	Roma
Italy	Ospedale San Camillo	Rome
Italy	Presidio Ospedaliero "M. Raimondi"	San Cataldo (Caltanisetta)	Caltanisetta
Italy	I.R.C.C.S. Policlinico San Donato	San Donato Milanese	Milano
Italy	A.O.U. "S. Maria della Misericordia di Udine"	Udine
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Rijnstate	Gelderland
Portugal	Hospital Prof. Doutor Fernando Fonseca E.P.E	Amadora	Lisbon
Portugal	Centro Hospitalar Barreiro Montijo, E.P.E	Barreiro
Portugal	Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria	Lisboa
Portugal	Centro Hospitalar entre Douro e Vouga E.P.E.	Santa Maria da Feira	Porto
Slovakia	FNsP F. D. Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia	Bratislava
Spain	Hospital de Alcorcon	Alcorcon	Madrid
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Arquitecto Marcide	Ferrol	A Coruna
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitari de Girona Dr. Josep Trueta	Girona	Barcelona
Spain	Hospital Universitario de Gran Canaria DR NEGRIN	Las Palmas De Gran Canari	Canarias
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Son Espases	Palma. Mallorca	Illes Balears
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Alvaro Cunqueiro	Pontevedra
Spain	Hospital de Sabadell	Sabadell	Barcelona
Spain	Hospital Universitario Infanta Sofia	San Sebastian De Los Reye	Madrid
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	A Coruna
Spain	Hospital de Galdakao	Usansolo	Bizkaia
Spain	Consorci Hospital General Universitari de Valencia	Valencia
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
United Kingdom	Heart of England NHS Foundation Trust	Birmingham
United Kingdom	The Royal Bournemouth Hospital	Bournemouth
United Kingdom	University Hospital Coventry	Coventry	WEST Midlands
United Kingdom	Dorset County Hospital	Dorchester	Dorset
United Kingdom	Royal Gwent Hospital	Exeter	Devon
United Kingdom	Gloucestershire Hospitals - NHS Foundation Trust	Gloucester	Gloucestershire
United Kingdom	Queen Alexandra Hospital	Hampshire
United Kingdom	Cwm Taf University Health Board	Llantrisant	Wales
United Kingdom	Salisbury NHS Foundation Trust	Salisbury	Wiltshire
United Kingdom	Southampton General Hospital	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Hospira, now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Belgium,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Portugal,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Characteristics of Participants: Disease Duration	Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline).	Baseline (Day 1)
Primary	Number of Participants Who Switched Treatment	Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported.	From baseline to follow-up period (up to a maximum duration of 2 years)
Primary	Reasons for Switching Treatment by Participants		From baseline to follow-up period (up to a maximum duration of 2 years)
Primary	Total Dose of Infusion Received	Total dose of infusion received by the participants was calculated.	From baseline to follow-up period (up to a maximum duration of 2 years)
Primary	Number of Participants by Frequency of Infusion Received	Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories.	Baseline (Day 1)
Primary	Number of Participants Who Had Change in Infusion Dose	Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.	From baseline to follow-up period (up to a maximum duration of 2 years)
Primary	Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change	Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest [AESI]/ serious adverse event [SAE]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category.	From baseline to follow-up period (up to a maximum duration of 2 years)
Primary	Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)		From baseline to follow-up period (up to a maximum duration of 2 years)
Primary	Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.	From baseline to follow-up period (up to a maximum duration of 2 years)
Secondary	Number of Participants Remaining in Clinical Remission or Relapse	Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first.	Months 6, 12, 18 and 24
Secondary	Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission	HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than [<] 5), mild disease (MD) (score equal to [=] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than [>] 16).	Baseline, Months 6, 12, 18 and 24
Secondary	Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity	HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score < 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score >16).	Baseline, Months 6, 12, 18 and 24
Secondary	Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission	Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6).	Baseline, Months 6, 12, 18 and 24
Secondary	Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity	Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6).	Baseline, Months 6, 12, 18 and 24
Secondary	Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis	The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing.	At Baseline
Secondary	Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location	The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted.	Baseline, Months 6, 12, 18 and 24
Secondary	Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity	The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.	Baseline, Months 6, 12, 18 and 24
Secondary	Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent	The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC.	Baseline, Months 6, 12, 18 and 24
Secondary	Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity	The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day [with or without blood], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily).	Baseline, Months 6, 12, 18 and 24
Secondary	Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index	The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity.	Baseline, Months 6, 12, 18 and 24
Secondary	Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24	C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.	Baseline, Months 6, 12, 18 and 24
Secondary	Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24	Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin.	Baseline, Months 6, 12, 18, and 24
Secondary	Number of Participants With Imaging Test Results	Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported.	From baseline up to follow-up period (a maximum of 2 years)