E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficacy of 2 SC administered regimens of golimumab in maintaining clinical response through Week 54 in subjects with moderately to severely active UC induced into clinical response with golimumab in the induction studies C0524T16 (EudraCT 2006-003397-94) or C0524T17 (EudraCT 2006-003398-28).
Evaluate the safety of 2 SC administered maintenance regimens of golimumab in subjects with moderately to severely active UC. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of golimumab in maintaining clinical remission at Weeks 30 and 54.
Evaluate the efficacy of golimumab in maintaining mucosal healing at Weeks 30 and 54.
Evaluate the efficacy of golimumab in maintaining clinical remission at Weeks 30 and 54 for subjects in clinical remission at Week 0.
Evaluate the efficacy of golimumab in achieving clinical remission and eliminating corticosteroid use at Week 54 among subjects receiving concomitant corticosteroids at Week 0. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have received all study agent administrations and completed the Week 6 Mayo score evaluation in one of the induction studies of golimumab for UC (ie, C0524T16, EudraCT 2006-003397-94 or C0524T17, EudraCT 2006-003398-28).
2. Are able to complete the Week 0 visit on the same day as the Week 6 visit of the induction study C0524T16 or C0524T17.
3. During the study and for 6 months after receiving the last administration of study agent, women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization). Women of childbearing potential must test negative for pregnancy.
4. Must be able and willing to adhere to the study visit schedule and comply with other protocol requirements.
5. Are capable of providing informed consent, which must be obtained prior to any study-related procedures.
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E.4 | Principal exclusion criteria |
1. Had any of the following changes to their concomitant UC medications (ie, oral 5 ASA compounds, oral corticosteroids, 6-MP, AZA, methotrexate [MTX]) since Week 0 of an induction study (C0524T16, EudraCT 2006-003397-94 or C0524T17, EudraCT 2006-003398-28):
a. an increased dose
b. initiation of a concomitant UC medication except for dose equivalent substitutions
2. Have received any of the following therapies since Week 0 of the induction study:
a. rectal corticosteroid therapy (ie, corticosteroids administered to the rectum or sigmoid colon via foam, enema, or suppository)
b. rectal 5-ASA compounds (ie, 5-ASA compounds administered to the rectum or sigmoid colon via foam, enema, or suppository)
c. parenteral corticosteroids
d. pentoxifylline
e. total parental nutrition (TPN)
f. antibiotics for the treatment of UC (including but not limited to ciprofloxacin, metronidazole, or rifaximin)
g. immunomodulatory agents other than 6-MP/AZA or MTX (including but not limited to 6-thioguanine [6-TG], cyclosporine, mycophenolate mofetil [MMF], tacrolimus, and sirolimus)
h. immunomodulatory biologic agents (including but not limited to infliximab, anakinra, etanercept, adalimumab, rituximab, natalizumab, visilizumab)
i. thalidomide or related agents
j. investigational drugs
k. apheresis (eg, Adacolumn apheresis)
3. Have had, in the opinion of the investigator, a clinically significant hypersensitivity reaction in an induction study (C0524T16 or C0524T17).
4. Have signs and symptoms of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis.
5. Have signs and symptoms of nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis).
6. Have had a clinically significant infection (eg, hepatitis, pneumonia, or pyelonephritis) or have received parenteral antibiotics for an infection since Week 0 of an induction study. Less serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.
7. Have signs and symptoms of infection with HIV, hepatitis B, or hepatitis C.
8. Have signs and symptoms of any malignancy.
9. Have signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphoma or lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or clinically significant hepatomegaly or splenomegaly.
10. Have signs and symptoms of CHF, including medically controlled asymptomatic CHF.
11. Have signs and symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.
12. Have signs and symptoms of systemic lupus erythematosus.
13. Have signs and symptoms of demyelinating disease, such as multiple sclerosis or optic neuritis.
14. Have undergone a colectomy (partial or total) or an ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Week 0 of the induction studies (C0524T16 or C0524T17).
15. Are pregnant or are planning pregnancy (both males and females) within 6 months following the last administration of study agent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is clinical response through Week 54. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) clinical remission at Weeks 30 and 54;
2) mucosal healing at Weeks 30 and 54;
3) clinical remission at Weeks 30 and 54 for subjects in remission at
Week 0;
4) clinical remission and elimination of corticosteroid use at Week 54
among subjects receiving corticosteroids at Week 0. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 155 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient, last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |