Ulcerative Colitis
Conditions
Brief summary
This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).
Detailed description
This is a prospective, observational, post-marketing safety surveillance registry of UC participants treated with Remicade or another standard therapy. Registry centers are targeted to enroll a total of 2000 participants (1000 Remicade participants and 1000 standard therapy participants) and to follow them for a period of up to 5 years. Participants who started the registry on standard therapy may switch over to Remicade.
Interventions
BIOLOGICALinfliximab
The treating physician will determine the treatment regimen and dose of Remicade.
DRUGStandard Therapy
The standard therapy group will consist of participants receiving a treatment regimen that does not include Remicade. The treatment of each standard therapy participant will be left to the discretion of the treating physician and may change during the course of a participant's participation in the registry.
Sponsors
Centocor, Inc.
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age, of either sex, and of any race. * Moderate-to-severe active UC, as defined by assessment by the treating physician. * Must, within 30 days of Baseline, either: * Initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), azathioprine (AZA), or methotrexate (participants in this category must be Remicade naïve) or * Initiate Remicade. Participants who have been treated in the past with Remicade, but who have discontinued for any reason and who are scheduled to receive Remicade within 30 days of the baseline visit must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion * Must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry. * Must be evaluated for active and inactive (latent) tuberculosis (TB) as suggested by local guidelines or as required by the Remicade label for participants starting Remicade.
Exclusion criteria
* Female who is known to be pregnant or nursing. * Previously treated with any other (investigational) biological drug for UC( other than Remicade) prior to Baseline. * In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry. * Participating in a blinded trial. In addition, participants with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Up to 5 years. | The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remicade Group Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion. | 1,059 |
| Standard Therapy Group Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition. | 1,180 |
| Total | 2,239 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 89 | 59 |
| Overall Study | Adverse Event | 28 | 27 |
| Overall Study | Lost to Follow-up | 169 | 250 |
| Overall Study | Withdrawal by Subject | 96 | 72 |
Baseline characteristics
| Characteristic | Remicade Group | Standard Therapy Group | Total |
|---|---|---|---|
| Age, Continuous | 40.3 Years STANDARD_DEVIATION 14.24 | 42.0 Years STANDARD_DEVIATION 15.44 | 41.2 Years STANDARD_DEVIATION 14.91 |
| Sex: Female, Male Female | 464 Participants | 541 Participants | 1005 Participants |
| Sex: Female, Male Male | 595 Participants | 639 Participants | 1234 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 321 / 1,059 | 173 / 1,180 | 70 / 296 |
| serious Total, serious adverse events | 439 / 1,059 | 294 / 1,180 | 102 / 296 |
Outcome results
Primary
Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories
The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities.
Time frame: Up to 5 years.
Population: All enrolled participants. The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Demyelinating Neurological Disorders | 0.1 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Fatalities | 0.8 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Autoimmune Disorders | 2.2 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Hepatobiliary Events | 4.4 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Serious Infection | 9.1 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Lymphoproliferative Disorders/ Malignancies | 3.7 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Hematologic Conditions | 4.2 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Infusion-Related Reactions | 13.0 Percentage of participants |
| Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Congestive Heart Failure | 0.3 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Infusion-Related Reactions | 0.2 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Demyelinating Neurological Disorders | 0.2 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Hematologic Conditions | 2.2 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Hepatobiliary Events | 3.6 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Fatalities | 1.3 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Lymphoproliferative Disorders/ Malignancies | 2.9 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Congestive Heart Failure | 0.3 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Autoimmune Disorders | 1.1 Percentage of participants |
| Standard Therapy Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Serious Infection | 3.4 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Fatalities | 0.3 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Congestive Heart Failure | 0.3 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Demyelinating Neurological Disorders | 0.3 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Hematologic Conditions | 4.1 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Lymphoproliferative Disorders/ Malignancies | 1.7 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Serious Infection | 10.5 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Autoimmune Disorders | 2.4 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Hepatobiliary Events | 4.1 Percentage of participants |
| Switched to Remicade Group | Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories | Infusion-Related Reactions | 8.8 Percentage of participants |