Crohn's Disease
Conditions
Brief summary
Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period
Interventions
BIOLOGICALRemicade
The treating physician will determine the treatment regimen and dose of Remicade.
Sponsors
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
* At least 18 years of age, of either sex, and of any race. * Must have active or fistulizing CD and must have experienced at least 1 of the following: * failed a tapering regimen of corticosteroids and will be initiating immunosuppressive therapy * required corticosteroid treatments for the previous 6 months and will be initiating immunosuppressive therapy * luminal or fistulizing CD, which, in the treating physician's judgment, qualifies for initiation of Remicade. * 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) at the Baseline Visit. TB evaluation will consist of TB history questions (eg, medical history, possible previous contact with TB, TB vaccination history). TB evaluation and TB screening (eg, skin test, chest x-ray) are required when a subject starts treatment with Remicade. In these cases, subjects must be screened for TB within 3 months prior to initiating Remicade treatment.
Exclusion criteria
* Female who is pregnant or nursing. * Treated with Remicade prior to Baseline. * Previously treated with other tumor necrosis factor (TNF)-active agents and other investigational drugs for CD prior to Baseline. * Active or untreated latent TB or other severe infections such as sepsis, abscesses, or opportunistic infections. * Moderate or severe heart failure (New York Heart Association \[NYHA\] Class III: subjects with marked limitation of activity; they are comfortable only at rest/Class IV: subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest). * Have lymphoproliferative disorders (eg, lymphoma) or malignancies. * In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry. * Are participating in any other clinical trials (excluding registries). In addition, subjects will be excluded from treatment with Remicade if any of the criteria listed below are met: * Females of childbearing potential unwilling to use a medically accepted method of birth control during treatment with Remicade and to continue its use for at least 6 months after the last Remicade treatment. * History of hypersensitivity to murine proteins or to any excipients of Remicade formulation (sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate). * Other conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Lymphoproliferative Disorders/Malignancies | Up to 5 Years | The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma. |
| Number of Participants With Serious Infections | Up to 5 Years | The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections. |
| Number of Participants With Infusion-Related Reactions/Hypersensitivity | Up to 5 Years | The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included. |
| Number of Participant Fatalities | Up to 5 Years | The number of participant fatalities was evaluated throughout the study. |
| Number of Participants With New or Worsening Congestive Heart Failure | Up to 5 Years | The number of participants with new or worsening congestive heart failure was evaluated throughout the study. |
| Number of Participants With Demyelinating Neurological Disorders | Up to 5 Years | The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis. |
| Number of Participants With Hematologic Conditions | Up to 5 Years | The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Assessment of Overall Health Status By Study Visit | Up to 5 Years | The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status. |
| The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Up to 5 Years | The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes. |
| Work/Daily Activity Status Score By Study Visit | Up to 5 Years | The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning. |
| Number of Participants With a Draining Fistula By Study Visit | Up to 5 Years | The number of participants with a draining fistula was evaluated at each study visit. |
| Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Up to 5 Years | The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. |
| Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Up to 5 Years | The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. |
| Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Up to 5 Years | The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit. |
Participant flow
Recruitment details
The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Remicade Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade. | 1,541 |
| Standard Therapy Group The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up. | 1,121 |
| Total | 2,662 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Initial Intervention | Administrative Reason | 51 | 38 |
| Initial Intervention | Adverse Event | 40 | 21 |
| Initial Intervention | Lost to Follow-up | 310 | 191 |
| Initial Intervention | Status completion unknown | 3 | 0 |
| Initial Intervention | Withdrawal by Subject | 114 | 71 |
| Switch to Remicade | Administrative Reason | 0 | 9 |
| Switch to Remicade | Adverse Event | 0 | 5 |
| Switch to Remicade | Lost to Follow-up | 0 | 23 |
| Switch to Remicade | Withdrawal by Subject | 0 | 12 |
Baseline characteristics
| Characteristic | Total | Remicade | Standard Therapy Group |
|---|---|---|---|
| Age, Continuous All Participants | 36.7 Years STANDARD_DEVIATION 12.9 | 36.1 Years STANDARD_DEVIATION 12.9 | 37.5 Years STANDARD_DEVIATION 12.86 |
| Age, Continuous Switched to Remicade | 36.7 Years STANDARD_DEVIATION 12.3 | NA Years | 36.7 Years STANDARD_DEVIATION 12.3 |
| Sex/Gender, Customized Female (All Participants) | 1612 Participants | 935 Participants | 677 Participants |
| Sex/Gender, Customized Female (Switched to Remicade) | NA Participants | NA Participants | 191 Participants |
| Sex/Gender, Customized Male (All Participants) | 1050 Participants | 606 Participants | 444 Participants |
| Sex/Gender, Customized Male (Switched to Remicade) | NA Participants | NA Participants | 107 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 | 173 / 1,121 | 441 / 1,541 | 51 / 298 |
| serious Total, serious adverse events | 391 / 1,121 | 792 / 1,541 | 136 / 298 |
Outcome results
Primary
Number of Participant Fatalities
The number of participant fatalities was evaluated throughout the study.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participant Fatalities | 30 Participants |
| Standard Therapy | Number of Participant Fatalities | 14 Participants |
| Switched to Remicade | Number of Participant Fatalities | 4 Participants |
Primary
Number of Participants With Demyelinating Neurological Disorders
The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participants With Demyelinating Neurological Disorders | 4 Participants |
| Standard Therapy | Number of Participants With Demyelinating Neurological Disorders | 1 Participants |
| Switched to Remicade | Number of Participants With Demyelinating Neurological Disorders | 0 Participants |
Primary
Number of Participants With Hematologic Conditions
The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participants With Hematologic Conditions | 50 Participants |
| Standard Therapy | Number of Participants With Hematologic Conditions | 11 Participants |
| Switched to Remicade | Number of Participants With Hematologic Conditions | 7 Participants |
Primary
Number of Participants With Infusion-Related Reactions/Hypersensitivity
The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participants With Infusion-Related Reactions/Hypersensitivity | 173 Participants |
| Standard Therapy | Number of Participants With Infusion-Related Reactions/Hypersensitivity | 1 Participants |
| Switched to Remicade | Number of Participants With Infusion-Related Reactions/Hypersensitivity | 28 Participants |
Primary
Number of Participants With Lymphoproliferative Disorders/Malignancies
The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participants With Lymphoproliferative Disorders/Malignancies | 49 Participants |
| Standard Therapy | Number of Participants With Lymphoproliferative Disorders/Malignancies | 21 Participants |
| Switched to Remicade | Number of Participants With Lymphoproliferative Disorders/Malignancies | 8 Participants |
Primary
Number of Participants With New or Worsening Congestive Heart Failure
The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participants With New or Worsening Congestive Heart Failure | 1 Participants |
| Standard Therapy | Number of Participants With New or Worsening Congestive Heart Failure | 1 Participants |
| Switched to Remicade | Number of Participants With New or Worsening Congestive Heart Failure | 0 Participants |
Primary
Number of Participants With Serious Infections
The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remicade | Number of Participants With Serious Infections | 132 Participants |
| Standard Therapy | Number of Participants With Serious Infections | 47 Participants |
| Switched to Remicade | Number of Participants With Serious Infections | 18 Participants |
Secondary
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 8 (n=98, 29, 23) | 9.5 Days | Standard Deviation 9.04 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 5 (n=105, 35, 34) | 11.7 Days | Standard Deviation 13.02 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 10 (n=85, 29, 27) | 10.1 Days | Standard Deviation 12.02 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 7 (n=109, 45, 25) | 10.6 Days | Standard Deviation 14.41 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 6 (n=107, 49, 19) | 10.8 Days | Standard Deviation 17.33 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 1 (Baseline; n=657,418 ,0) | 12.2 Days | Standard Deviation 13.73 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 3 (n=216, 58, 35) | 14.2 Days | Standard Deviation 16.83 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 2 (n=304,126, 33) | 14.4 Days | Standard Deviation 17.81 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 9 (n=80, 38, 17) | 12.4 Days | Standard Deviation 14.44 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 4 (n=151, 60, 24) | 12.6 Days | Standard Deviation 15.23 |
| Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 11 (n=63, 19, 18) | 11.4 Days | Standard Deviation 13.24 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 6 (n=107, 49, 19) | 13.7 Days | Standard Deviation 27.34 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 1 (Baseline; n=657,418 ,0) | 10.8 Days | Standard Deviation 10.93 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 2 (n=304,126, 33) | 12.0 Days | Standard Deviation 14.26 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 3 (n=216, 58, 35) | 9.4 Days | Standard Deviation 7.49 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 4 (n=151, 60, 24) | 8.5 Days | Standard Deviation 11.87 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 5 (n=105, 35, 34) | 9.8 Days | Standard Deviation 9.49 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 7 (n=109, 45, 25) | 10.2 Days | Standard Deviation 10.63 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 8 (n=98, 29, 23) | 16.3 Days | Standard Deviation 15.52 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 9 (n=80, 38, 17) | 6.9 Days | Standard Deviation 5.77 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 10 (n=85, 29, 27) | 8.0 Days | Standard Deviation 5.41 |
| Standard Therapy | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 11 (n=63, 19, 18) | 8.7 Days | Standard Deviation 10.64 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 10 (n=85, 29, 27) | 9.0 Days | Standard Deviation 6.4 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 8 (n=98, 29, 23) | 14.7 Days | Standard Deviation 17.29 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 3 (n=216, 58, 35) | 13.5 Days | Standard Deviation 13.65 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 1 (Baseline; n=657,418 ,0) | NA Days | — |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 9 (n=80, 38, 17) | 10.7 Days | Standard Deviation 17.2 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 2 (n=304,126, 33) | 13.0 Days | Standard Deviation 12.23 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 6 (n=107, 49, 19) | 18.3 Days | Standard Deviation 17.81 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 5 (n=105, 35, 34) | 7.1 Days | Standard Deviation 6.21 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 11 (n=63, 19, 18) | 18.1 Days | Standard Deviation 31.57 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 7 (n=109, 45, 25) | 10.0 Days | Standard Deviation 11.33 |
| Switched to Remicade | Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 4 (n=151, 60, 24) | 9.1 Days | Standard Deviation 10.82 |
Secondary
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 8 (n=1099, 589, 233) | 0.1 Hospital Stays | Standard Deviation 0.76 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 5 (n=1221, 714, 188) | 0.1 Hospital Stays | Standard Deviation 0.54 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 10 (n=1031, 535, 235) | 0.1 Hospital Stays | Standard Deviation 0.46 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 7 (n=1111, 615, 219) | 0.1 Hospital Stays | Standard Deviation 0.4 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 6 (n=1170, 665, 208) | 0.1 Hospital Stays | Standard Deviation 0.66 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 1 (Baseline; n=1539, 1121, 0) | 0.7 Hospital Stays | Standard Deviation 1.25 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 3 (n=1334, 827, 152) | 0.3 Hospital Stays | Standard Deviation 0.92 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 2 (n=1418, 920, 100) | 0.3 Hospital Stays | Standard Deviation 0.87 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 9 (n=1046, 562, 229) | 0.1 Hospital Stays | Standard Deviation 0.68 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 4 (n=1285, 779, 168) | 0.2 Hospital Stays | Standard Deviation 0.56 |
| Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 11 (n=1006, 541, 248) | 0.1 Hospital Stays | Standard Deviation 0.35 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 6 (n=1170, 665, 208) | 0.1 Hospital Stays | Standard Deviation 0.33 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 1 (Baseline; n=1539, 1121, 0) | 0.5 Hospital Stays | Standard Deviation 0.81 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 2 (n=1418, 920, 100) | 0.2 Hospital Stays | Standard Deviation 0.5 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 3 (n=1334, 827, 152) | 0.1 Hospital Stays | Standard Deviation 0.38 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 4 (n=1285, 779, 168) | 0.2 Hospital Stays | Standard Deviation 3.08 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 5 (n=1221, 714, 188) | 0.1 Hospital Stays | Standard Deviation 0.28 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 7 (n=1111, 615, 219) | 0.1 Hospital Stays | Standard Deviation 0.43 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 8 (n=1099, 589, 233) | 0.1 Hospital Stays | Standard Deviation 0.42 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 9 (n=1046, 562, 229) | 0.1 Hospital Stays | Standard Deviation 0.5 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 10 (n=1031, 535, 235) | 0.1 Hospital Stays | Standard Deviation 0.42 |
| Standard Therapy | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 11 (n=1006, 541, 248) | 0.1 Hospital Stays | Standard Deviation 2.59 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 10 (n=1031, 535, 235) | 0.1 Hospital Stays | Standard Deviation 0.44 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 8 (n=1099, 589, 233) | 0.1 Hospital Stays | Standard Deviation 0.49 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 3 (n=1334, 827, 152) | 0.4 Hospital Stays | Standard Deviation 0.86 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 1 (Baseline; n=1539, 1121, 0) | NA Hospital Stays | — |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 9 (n=1046, 562, 229) | 0.1 Hospital Stays | Standard Deviation 0.31 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 2 (n=1418, 920, 100) | 0.5 Hospital Stays | Standard Deviation 0.76 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 6 (n=1170, 665, 208) | 0.1 Hospital Stays | Standard Deviation 0.49 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 5 (n=1221, 714, 188) | 0.3 Hospital Stays | Standard Deviation 0.72 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 11 (n=1006, 541, 248) | 0.1 Hospital Stays | Standard Deviation 0.42 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 7 (n=1111, 615, 219) | 0.2 Hospital Stays | Standard Deviation 0.55 |
| Switched to Remicade | Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months | Visit 4 (n=1285, 779, 168) | 0.2 Hospital Stays | Standard Deviation 0.67 |
Secondary
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 8 (n=98, 29, 23) | 43 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 5 (n=106, 36, 34) | 50 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 10 (n=85, 29, 27) | 38 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 7 (n=109, 45, 25) | 48 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 6 (n=108, 49, 19) | 49 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 1 (Basline; n=660, 419, 0) | 171 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 3 (n=217, 57, 36) | 121 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 2 (n=304, 126, 33) | 135 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 9 (n=82, 38, 17) | 38 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 4 (n=153, 60, 24) | 68 Surgical Procedures |
| Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 11 (n=63, 19, 18) | 34 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 6 (n=108, 49, 19) | 21 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 1 (Basline; n=660, 419, 0) | 81 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 2 (n=304, 126, 33) | 51 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 3 (n=217, 57, 36) | 23 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 4 (n=153, 60, 24) | 16 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 5 (n=106, 36, 34) | 14 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 7 (n=109, 45, 25) | 20 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 8 (n=98, 29, 23) | 12 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 9 (n=82, 38, 17) | 13 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 10 (n=85, 29, 27) | 13 Surgical Procedures |
| Standard Therapy | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 11 (n=63, 19, 18) | 6 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 10 (n=85, 29, 27) | 8 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 8 (n=98, 29, 23) | 7 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 3 (n=217, 57, 36) | 12 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 1 (Basline; n=660, 419, 0) | NA Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 9 (n=82, 38, 17) | 8 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 2 (n=304, 126, 33) | 7 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 6 (n=108, 49, 19) | 11 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 5 (n=106, 36, 34) | 14 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 11 (n=63, 19, 18) | 8 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 7 (n=109, 45, 25) | 6 Surgical Procedures |
| Switched to Remicade | Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months | Visit 4 (n=153, 60, 24) | 8 Surgical Procedures |
Secondary
Number of Participants With a Draining Fistula By Study Visit
The number of participants with a draining fistula was evaluated at each study visit.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 4 (n=1285, 779, 168) | 146 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 3 (n=1334, 827, 152) | 170 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 10 (n=1030, 535, 235) | 85 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 5 (n=1221, 714, 188) | 125 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 9 (n=1046, 562, 229) | 98 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 2 (n=1420, 920, 100) | 211 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 6 (n=1169, 666, 208) | 114 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 8 (n=1097, 588, 233) | 105 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 11 (n=1006, 541, 248) | 87 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 7 (n=1110, 615, 219) | 97 Participants |
| Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 1 (Baseline; n=1541, 1120, 0) | 349 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 7 (n=1110, 615, 219) | 31 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 8 (n=1097, 588, 233) | 23 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 9 (n=1046, 562, 229) | 32 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 10 (n=1030, 535, 235) | 15 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 3 (n=1334, 827, 152) | 41 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 4 (n=1285, 779, 168) | 31 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 1 (Baseline; n=1541, 1120, 0) | 96 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 5 (n=1221, 714, 188) | 29 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 6 (n=1169, 666, 208) | 26 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 2 (n=1420, 920, 100) | 51 Participants |
| Standard Therapy | Number of Participants With a Draining Fistula By Study Visit | Visit 11 (n=1006, 541, 248) | 16 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 11 (n=1006, 541, 248) | 20 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 1 (Baseline; n=1541, 1120, 0) | NA Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 2 (n=1420, 920, 100) | 16 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 3 (n=1334, 827, 152) | 19 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 4 (n=1285, 779, 168) | 12 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 5 (n=1221, 714, 188) | 15 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 6 (n=1169, 666, 208) | 15 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 7 (n=1110, 615, 219) | 15 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 9 (n=1046, 562, 229) | 15 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 10 (n=1030, 535, 235) | 20 Participants |
| Switched to Remicade | Number of Participants With a Draining Fistula By Study Visit | Visit 8 (n=1097, 588, 233) | 16 Participants |
Secondary
Participant Assessment of Overall Health Status By Study Visit
The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 8 (n=1044, 573, 221) | 3.1 Score on a Scale | Standard Deviation 1.46 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 5 (n=1160, 704, 184) | 3.1 Score on a Scale | Standard Deviation 1.44 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 1 (Baseline; n=1526, 1116, 0) | 4.3 Score on a Scale | Standard Deviation 1.33 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 7 (n=1046, 606, 212) | 3.1 Score on a Scale | Standard Deviation 1.47 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 6 (n=1110, 649, 202) | 3.1 Score on a Scale | Standard Deviation 1.43 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 10 (n=963, 520, 227) | 3.0 Score on a Scale | Standard Deviation 1.42 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 3 (n=1280, 809, 146) | 3.2 Score on a Scale | Standard Deviation 1.41 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 11 (n=956, 527, 235) | 3.0 Score on a Scale | Standard Deviation 1.41 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 9 (n=999, 544, 223) | 3.1 Score on a Scale | Standard Deviation 1.45 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 4 (n=1217, 755, 162) | 3.2 Score on a Scale | Standard Deviation 1.43 |
| Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 2 (n=1344, 903, 95) | 3.3 Score on a Scale | Standard Deviation 1.44 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 1 (Baseline; n=1526, 1116, 0) | 3.9 Score on a Scale | Standard Deviation 1.38 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 2 (n=1344, 903, 95) | 3.3 Score on a Scale | Standard Deviation 1.44 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 3 (n=1280, 809, 146) | 3.1 Score on a Scale | Standard Deviation 1.4 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 4 (n=1217, 755, 162) | 3.0 Score on a Scale | Standard Deviation 1.38 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 5 (n=1160, 704, 184) | 3.1 Score on a Scale | Standard Deviation 1.42 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 6 (n=1110, 649, 202) | 3.0 Score on a Scale | Standard Deviation 1.41 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 7 (n=1046, 606, 212) | 3.0 Score on a Scale | Standard Deviation 1.41 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 8 (n=1044, 573, 221) | 3.0 Score on a Scale | Standard Deviation 1.44 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 9 (n=999, 544, 223) | 2.9 Score on a Scale | Standard Deviation 1.41 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 10 (n=963, 520, 227) | 2.8 Score on a Scale | Standard Deviation 1.44 |
| Standard Therapy | Participant Assessment of Overall Health Status By Study Visit | Visit 11 (n=956, 527, 235) | 2.8 Score on a Scale | Standard Deviation 1.43 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 10 (n=963, 520, 227) | 3.1 Score on a Scale | Standard Deviation 1.38 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 8 (n=1044, 573, 221) | 3.2 Score on a Scale | Standard Deviation 1.43 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 3 (n=1280, 809, 146) | 3.6 Score on a Scale | Standard Deviation 1.41 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 1 (Baseline; n=1526, 1116, 0) | NA Score on a Scale | — |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 9 (n=999, 544, 223) | 3.2 Score on a Scale | Standard Deviation 1.5 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 2 (n=1344, 903, 95) | 3.9 Score on a Scale | Standard Deviation 1.49 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 6 (n=1110, 649, 202) | 3.4 Score on a Scale | Standard Deviation 1.44 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 5 (n=1160, 704, 184) | 3.2 Score on a Scale | Standard Deviation 1.52 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 11 (n=956, 527, 235) | 3.1 Score on a Scale | Standard Deviation 1.47 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 7 (n=1046, 606, 212) | 3.3 Score on a Scale | Standard Deviation 1.42 |
| Switched to Remicade | Participant Assessment of Overall Health Status By Study Visit | Visit 4 (n=1217, 755, 162) | 3.5 Score on a Scale | Standard Deviation 1.45 |
Secondary
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.
Time frame: Up to 5 Years
Population: The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 1 (Baseline; n=1505, 1106, 0) | 8.2 Score on a Scale | Standard Deviation 5.36 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 3 (n=1250, 785, 143) | 3.7 Score on a Scale | Standard Deviation 3.87 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 10 (n=936, 526, 225) | 3.4 Score on a Scale | Standard Deviation 4.23 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 11 (n=918, 525, 238) | 3.4 Score on a Scale | Standard Deviation 3.93 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 6 (n=1070, 647, 199) | 3.6 Score on a Scale | Standard Deviation 4 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 4 (n=1196, 742, 159) | 3.8 Score on a Scale | Standard Deviation 4.01 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 9 (n=953, 546, 219) | 3.6 Score on a Scale | Standard Deviation 4.5 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 5 (n=1127, 692, 181) | 3.7 Score on a Scale | Standard Deviation 3.95 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 2 (n=1320, 876, 91) | 4.1 Score on a Scale | Standard Deviation 4.13 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 7 (n=1023, 592, 209) | 3.6 Score on a Scale | Standard Deviation 4 |
| Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 8 (n=1015, 562, 224) | 3.6 Score on a Scale | Standard Deviation 3.97 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 7 (n=1023, 592, 209) | 3.0 Score on a Scale | Standard Deviation 3.36 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 8 (n=1015, 562, 224) | 3.2 Score on a Scale | Standard Deviation 3.63 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 4 (n=1196, 742, 159) | 3.2 Score on a Scale | Standard Deviation 3.56 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 9 (n=953, 546, 219) | 2.9 Score on a Scale | Standard Deviation 2.9 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 3 (n=1250, 785, 143) | 3.5 Score on a Scale | Standard Deviation 3.64 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 6 (n=1070, 647, 199) | 3.1 Score on a Scale | Standard Deviation 3.39 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 10 (n=936, 526, 225) | 2.7 Score on a Scale | Standard Deviation 3.38 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 1 (Baseline; n=1505, 1106, 0) | 6.2 Score on a Scale | Standard Deviation 4.94 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 2 (n=1320, 876, 91) | 3.8 Score on a Scale | Standard Deviation 3.84 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 11 (n=918, 525, 238) | 2.7 Score on a Scale | Standard Deviation 3.44 |
| Standard Therapy | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 5 (n=1127, 692, 181) | 3.4 Score on a Scale | Standard Deviation 3.51 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 11 (n=918, 525, 238) | 4.2 Score on a Scale | Standard Deviation 4.29 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 1 (Baseline; n=1505, 1106, 0) | NA Score on a Scale | — |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 2 (n=1320, 876, 91) | 6.0 Score on a Scale | Standard Deviation 5.28 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 3 (n=1250, 785, 143) | 4.4 Score on a Scale | Standard Deviation 4.05 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 4 (n=1196, 742, 159) | 4.8 Score on a Scale | Standard Deviation 4.47 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 5 (n=1127, 692, 181) | 4.9 Score on a Scale | Standard Deviation 5.81 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 6 (n=1070, 647, 199) | 4.5 Score on a Scale | Standard Deviation 4.29 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 7 (n=1023, 592, 209) | 4.1 Score on a Scale | Standard Deviation 4.43 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 8 (n=1015, 562, 224) | 4.1 Score on a Scale | Standard Deviation 4.69 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 9 (n=953, 546, 219) | 4.4 Score on a Scale | Standard Deviation 5.23 |
| Switched to Remicade | The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit | Visit 10 (n=936, 526, 225) | 4.3 Score on a Scale | Standard Deviation 4.66 |
Secondary
Work/Daily Activity Status Score By Study Visit
The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.
Time frame: Up to 5 Years
Population: The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 8 (n=1025, 571, 221) | 3.3 Score on a Scale | Standard Deviation 2.75 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 5 (n=1128, 694, 179) | 3.4 Score on a Scale | Standard Deviation 2.76 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 10 (n=934, 514, 225) | 3.1 Score on a Scale | Standard Deviation 2.66 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 7 (n=1030, 601, 207) | 3.2 Score on a Scale | Standard Deviation 2.7 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 6 (n=1077, 638, 201) | 3.3 Score on a Scale | Standard Deviation 2.75 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 1 (Baseline; n=1496, 1108, 0) | 5.9 Score on a Scale | Standard Deviation 2.61 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 3 (n=1235, 797, 143) | 3.8 Score on a Scale | Standard Deviation 2.76 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 2 (n=1316, 895, 94) | 4.2 Score on a Scale | Standard Deviation 2.86 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 9 (n=982, 542, 222) | 3.3 Score on a Scale | Standard Deviation 2.75 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 4 (n=1192, 738, 159) | 3.6 Score on a Scale | Standard Deviation 2.79 |
| Remicade | Work/Daily Activity Status Score By Study Visit | Visit 11 (n=925, 521, 235) | 3.2 Score on a Scale | Standard Deviation 2.67 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 6 (n=1077, 638, 201) | 2.7 Score on a Scale | Standard Deviation 2.56 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 1 (Baseline; n=1496, 1108, 0) | 4.9 Score on a Scale | Standard Deviation 2.83 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 2 (n=1316, 895, 94) | 3.7 Score on a Scale | Standard Deviation 2.79 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 3 (n=1235, 797, 143) | 3.2 Score on a Scale | Standard Deviation 2.77 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 4 (n=1192, 738, 159) | 2.9 Score on a Scale | Standard Deviation 2.6 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 5 (n=1128, 694, 179) | 3.0 Score on a Scale | Standard Deviation 2.63 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 7 (n=1030, 601, 207) | 2.8 Score on a Scale | Standard Deviation 2.62 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 8 (n=1025, 571, 221) | 2.7 Score on a Scale | Standard Deviation 2.59 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 9 (n=982, 542, 222) | 2.6 Score on a Scale | Standard Deviation 2.46 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 10 (n=934, 514, 225) | 2.4 Score on a Scale | Standard Deviation 2.53 |
| Standard Therapy | Work/Daily Activity Status Score By Study Visit | Visit 11 (n=925, 521, 235) | 2.4 Score on a Scale | Standard Deviation 2.44 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 10 (n=934, 514, 225) | 3.6 Score on a Scale | Standard Deviation 2.71 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 8 (n=1025, 571, 221) | 3.5 Score on a Scale | Standard Deviation 2.74 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 3 (n=1235, 797, 143) | 4.8 Score on a Scale | Standard Deviation 2.94 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 1 (Baseline; n=1496, 1108, 0) | NA Score on a Scale | — |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 9 (n=982, 542, 222) | 3.5 Score on a Scale | Standard Deviation 2.78 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 2 (n=1316, 895, 94) | 5.5 Score on a Scale | Standard Deviation 2.81 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 6 (n=1077, 638, 201) | 3.9 Score on a Scale | Standard Deviation 2.87 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 5 (n=1128, 694, 179) | 4.0 Score on a Scale | Standard Deviation 2.89 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 11 (n=925, 521, 235) | 3.6 Score on a Scale | Standard Deviation 2.76 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 7 (n=1030, 601, 207) | 3.6 Score on a Scale | Standard Deviation 2.85 |
| Switched to Remicade | Work/Daily Activity Status Score By Study Visit | Visit 4 (n=1192, 738, 159) | 4.3 Score on a Scale | Standard Deviation 2.95 |