Ulcerative Colitis MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 47
Sponsors
MSD Belgium BVBA/SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject must be willing and able to provide written informed consent for the trial. 2. Each subject must be ?18 years of age 3. Anti-TNF naïve adults with established diagnosis of UC and moderate to severe disease activity. The patient must also meet the following criteria: Mayo score = 6, including an endoscopic subscore = 2; and a previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or6-mercaptopurine (6-MP) or azathioprine (AZA), unless the patient is intolerant to or have medical contraindications for such therapies (should be documented). 4. Anti-TNF experienced adults with established diagnosis of UC and moderate to severe disease activity, either not responding, partially responding or intolerant to Remicade. The patient must also meet the following criteria: Mayo score = 6, including an endoscopic subscore = 2; and a previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or6-mercaptopurine (6-MP) or azathioprine (AZA), unless the patient is intolerant to or have medical contraindications for such therapies (should be documented). 5. Sexually active women of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 6 months after stopping the medication. Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed consent to provide information regarding any pregnancy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. The subject previously self-injected any agent for any condition. 2. The subject has concomitant use of other biological agents 3. The subject has had active tuberculosis within 12 months prior to the first injection or has suspected latent tuberculosis as indicated by a positive tuberculin skin test within one month prior to the first administration of golimumab or a positive chest radiograph within 3 months prior the first administration of golimumab. In case of a positive tuberculin skin test and/or chest radiograph, latent tuberculosis must be determined by a pneumologist and treated prophylactically. 4. The subject has an active clinical non-tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, Pneumocystis carinii, aspergillosis, etc.) within 6 months prior to the first injection. 5. The subject has had an active infection and/or serious infection (HIV, hepatitis, pneumonia, pyelonephritis, severe sepsis) within 6 months prior to the first golimumab injection. 6. The subject has had a live viral or bacterial vaccination within 3 months prior to the first golimumab injection or Bacillus Calmette-Guérin vaccination within 12 months prior to the first golimumab injection. 7. The subject has evidence of heart failure NYHA class 3-4 8. The subject has a history of demyelinating disease, such as multiple sclerosis or optic neuritis 9. The subject has a history of systemic lupus erythematosus 10. The subject has a history of lymphoproliferative disease, or any unknown malignancy or history of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence. 11. The subject has an active hepatitis B infection. 12. The subject has an allergy or hypersensitivity to golimumab or its excipients. 13. The subject is pregnant or breast feeding 14. The subject is latex sensitive 15. The subject has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial. 16. The subject or a family member is among the personnel of the investigational or sponsor staff directly involved with this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether UC patients prefer to administer Simponi® using the SmartJect® autoinjector, using a prefilled syringe, or are undecided.;Secondary Objective: • Determine which of the two delivery systems subjects consider easiest to use and resulting in the least discomfort. • Determine how patient characteristics (disease severity, age, sex, educational level) influence device preference. ;Primary end point(s): The primary preference endpoint is overall device preference as determined by the Preference Questionnaire.;Timepoint(s) of evaluation of this end point: Two weeks after administration of Simponi by two delivery methods | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary preference endpoints are subject’s preference of device for the following aspects: • Ease of use • Least discomfort ;Timepoint(s) of evaluation of this end point: Two weeks after administration of Simponi by two delivery methods | — |
Countries
Belgium
Contacts
Public ContactMarian Coquel
MSD Belgium BVBA/SPRL
Outcome results
None listed