A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis--Rollover Study
Summary: The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis.
| HR#: |
17942 |
| PRINCIPAL INVESTIGATOR: |
Lawrence Comerford, , MD, MS |
| SPONSOR: |
|
| TARGET ENROLLMENT: |
6 |
| DISEASE TYPE: |
Ulcerative Colitis |
| BODY LOCATION(S): |
Large Intestine, |
| PRIMARY OBJECTIVE: |
1. 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 goolimumab in the infuction studies C0524T16 or C0524T17.
2. Evaluate the safety of 2 SC administered maintenance regimens of golimumab in subjects with moderately to severely active UC. |
| SECONDARY OBJECTIVE(S): |
1. Evaluate the efficacy of golimumab in maintaining clinical remission at Week 30 and 54.
2. Evaluate the efficacy of golimumab in maintaining mucosal hearing at Weeks 30 and 54.
3. Evaluate the efficacy of golimumab in maintaining clinical remission at Weeks 30 and 54 for subjects in clinical remission at Week 0.
4. Evaluate the efficacy of golimumamb in achieving clinical remission and eliminating corticosteroid use at Week 54 among subjects receiving concomitant corticosteroids at Week 0. |
| 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 or C0524T17). |
|
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. |
|
| 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 or C0524T17):
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 or enema)
b. rectal 5-ASA compounds (ie, 5-ASA compounds administered to the rectum or sigmoid colon via foam or enema)
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 TMX (including but not limited to 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, sych as lymphoma or lymphadenopathy of unusual size of 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. |
|
| TREATMENT GROUPS: |
|
| LENGTH OF STUDY: |
|
| CONTACTS: |
- Rebekah Whichard, , BA, CCRC (Primary Study Coordinator)
(843) 876-7233 or richreb@musc.edu
- Kyle Orrell, MSHP (DDC Research Program Manager)
843-876-4303 or orrell@musc.edu
- Lawrence Comerford, , MD, MS (Principal Investigator)
(843) 876-4262 or comerfol@musc.edu
|
|