An observational study in Crohn's Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by Merck Sharp & Dohme LLC · Observational
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
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 2,662 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult subjects, ages 18 years and older, with a diagnosis of active or fistulizing CD with no previous exposure to Remicade will be eligible to enroll into the registry.
Must have active or fistulizing CD and must have experienced at least 1 of the following:
Exclusion Criteria:
In addition, subjects will be excluded from treatment with Remicade if any of the criteria listed below are met:
Particpiants with no prior exposure to Remicade, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who start on Remicade will constitute the Remicade Group, regardless of whether they continue with Remicade or switch to another treatment.
Biological: Remicade
Participants who are being treated with standard therapy and are not adequately maintained and will be offered an alternative treatment that does not include Remicade. Standard therapy participants must not have previously received Remicade.
Participants who started in the Standard Therapy Group but switched over to Remicade sometime during the follow-up period. Participants who switch to Remicade are evaluated in the Standard Therapy group until the time of the switch and are evaluated in the Switched to Remicade group thereafter.
Biological: Remicade
The treating physician will determine the treatment regimen and dose of Remicade.
Also known as: Infliximab, SCH 215596
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
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
Number of Participant Fatalities
The number of participant fatalities was evaluated throughout the study.
Time frame: Up to 5 Years
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Remicade | Standard Therapy Group |
|---|---|---|
| Started | 1541 | 1121 |
| Completed | 1023 | 800 |
| Not completed | 518 | 321 |
| Withdrew: Adverse event | 40 | 21 |
| Withdrew: Lost to follow-up | 310 | 191 |
| Withdrew: Withdrawal by subject | 114 | 71 |
| Withdrew: Administrative reason | 51 | 38 |
| Withdrew: Status completion unknown | 3 | 0 |
| Milestone | Remicade | Standard Therapy Group |
|---|---|---|
| Started | 0 | 298 |
| Completed | 0 | 249 |
| Not completed | 0 | 49 |
| Withdrew: Adverse event | 0 | 5 |
| Withdrew: Lost to follow-up | 0 | 23 |
| Withdrew: Withdrawal by subject | 0 | 12 |
| Withdrew: Administrative reason | 0 | 9 |
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.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participants With Serious Infections | 132 | 47 | 18 |
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.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participants With Infusion-Related Reactions/Hypersensitivity | 173 | 1 | 28 |
The number of participant fatalities was evaluated throughout the study.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participant Fatalities | 30 | 14 | 4 |
The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participants With New or Worsening Congestive Heart Failure | 1 | 1 | 0 |
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.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participants With Demyelinating Neurological Disorders | 4 | 1 | 0 |
The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participants With Hematologic Conditions | 50 | 11 | 7 |
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.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Number of Participants With Lymphoproliferative Disorders/Malignancies | 49 | 21 | 8 |
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.
| Score on a Scale | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Baseline; n=1526, 1116, 0) | 4.3 ± 1.33 | 3.9 ± 1.38 | NA ± NA |
| Visit 2 (n=1344, 903, 95) | 3.3 ± 1.44 | 3.3 ± 1.44 | 3.9 ± 1.49 |
| Visit 3 (n=1280, 809, 146) | 3.2 ± 1.41 | 3.1 ± 1.40 | 3.6 ± 1.41 |
| Visit 4 (n=1217, 755, 162) | 3.2 ± 1.43 | 3.0 ± 1.38 | 3.5 ± 1.45 |
| Visit 5 (n=1160, 704, 184) | 3.1 ± 1.44 | 3.1 ± 1.42 | 3.2 ± 1.52 |
| Visit 6 (n=1110, 649, 202) | 3.1 ± 1.43 | 3.0 ± 1.41 | 3.4 ± 1.44 |
| Visit 7 (n=1046, 606, 212) | 3.1 ± 1.47 | 3.0 ± 1.41 | 3.3 ± 1.42 |
| Visit 8 (n=1044, 573, 221) | 3.1 ± 1.46 | 3.0 ± 1.44 | 3.2 ± 1.43 |
| Visit 9 (n=999, 544, 223) | 3.1 ± 1.45 | 2.9 ± 1.41 | 3.2 ± 1.50 |
| Visit 10 (n=963, 520, 227) | 3.0 ± 1.42 | 2.8 ± 1.44 | 3.1 ± 1.38 |
| Visit 11 (n=956, 527, 235) | 3.0 ± 1.41 | 2.8 ± 1.43 | 3.1 ± 1.47 |
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.
| Score on a Scale | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Baseline; n=1505, 1106, 0) | 8.2 ± 5.36 | 6.2 ± 4.94 | NA ± NA |
| Visit 2 (n=1320, 876, 91) | 4.1 ± 4.13 | 3.8 ± 3.84 | 6.0 ± 5.28 |
| Visit 3 (n=1250, 785, 143) | 3.7 ± 3.87 | 3.5 ± 3.64 | 4.4 ± 4.05 |
| Visit 4 (n=1196, 742, 159) | 3.8 ± 4.01 | 3.2 ± 3.56 | 4.8 ± 4.47 |
| Visit 5 (n=1127, 692, 181) | 3.7 ± 3.95 | 3.4 ± 3.51 | 4.9 ± 5.81 |
| Visit 6 (n=1070, 647, 199) | 3.6 ± 4.00 | 3.1 ± 3.39 | 4.5 ± 4.29 |
| Visit 7 (n=1023, 592, 209) | 3.6 ± 4.00 | 3.0 ± 3.36 | 4.1 ± 4.43 |
| Visit 8 (n=1015, 562, 224) | 3.6 ± 3.97 | 3.2 ± 3.63 | 4.1 ± 4.69 |
| Visit 9 (n=953, 546, 219) | 3.6 ± 4.50 | 2.9 ± 2.90 | 4.4 ± 5.23 |
| Visit 10 (n=936, 526, 225) | 3.4 ± 4.23 | 2.7 ± 3.38 | 4.3 ± 4.66 |
| Visit 11 (n=918, 525, 238) | 3.4 ± 3.93 | 2.7 ± 3.44 | 4.2 ± 4.29 |
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.
| Score on a Scale | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Baseline; n=1496, 1108, 0) | 5.9 ± 2.61 | 4.9 ± 2.83 | NA ± NA |
| Visit 2 (n=1316, 895, 94) | 4.2 ± 2.86 | 3.7 ± 2.79 | 5.5 ± 2.81 |
| Visit 3 (n=1235, 797, 143) | 3.8 ± 2.76 | 3.2 ± 2.77 | 4.8 ± 2.94 |
| Visit 4 (n=1192, 738, 159) | 3.6 ± 2.79 | 2.9 ± 2.60 | 4.3 ± 2.95 |
| Visit 5 (n=1128, 694, 179) | 3.4 ± 2.76 | 3.0 ± 2.63 | 4.0 ± 2.89 |
| Visit 6 (n=1077, 638, 201) | 3.3 ± 2.75 | 2.7 ± 2.56 | 3.9 ± 2.87 |
| Visit 7 (n=1030, 601, 207) | 3.2 ± 2.70 | 2.8 ± 2.62 | 3.6 ± 2.85 |
| Visit 8 (n=1025, 571, 221) | 3.3 ± 2.75 | 2.7 ± 2.59 | 3.5 ± 2.74 |
| Visit 9 (n=982, 542, 222) | 3.3 ± 2.75 | 2.6 ± 2.46 | 3.5 ± 2.78 |
| Visit 10 (n=934, 514, 225) | 3.1 ± 2.66 | 2.4 ± 2.53 | 3.6 ± 2.71 |
| Visit 11 (n=925, 521, 235) | 3.2 ± 2.67 | 2.4 ± 2.44 | 3.6 ± 2.76 |
The number of participants with a draining fistula was evaluated at each study visit.
| Participants | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Baseline; n=1541, 1120, 0) | 349 | 96 | NA |
| Visit 2 (n=1420, 920, 100) | 211 | 51 | 16 |
| Visit 3 (n=1334, 827, 152) | 170 | 41 | 19 |
| Visit 4 (n=1285, 779, 168) | 146 | 31 | 12 |
| Visit 5 (n=1221, 714, 188) | 125 | 29 | 15 |
| Visit 6 (n=1169, 666, 208) | 114 | 26 | 15 |
| Visit 7 (n=1110, 615, 219) | 97 | 31 | 15 |
| Visit 8 (n=1097, 588, 233) | 105 | 23 | 16 |
| Visit 9 (n=1046, 562, 229) | 98 | 32 | 15 |
| Visit 10 (n=1030, 535, 235) | 85 | 15 | 20 |
| Visit 11 (n=1006, 541, 248) | 87 | 16 | 20 |
The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
| Hospital Stays | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Baseline; n=1539, 1121, 0) | 0.7 ± 1.25 | 0.5 ± 0.81 | NA ± NA |
| Visit 2 (n=1418, 920, 100) | 0.3 ± 0.87 | 0.2 ± 0.50 | 0.5 ± 0.76 |
| Visit 3 (n=1334, 827, 152) | 0.3 ± 0.92 | 0.1 ± 0.38 | 0.4 ± 0.86 |
| Visit 4 (n=1285, 779, 168) | 0.2 ± 0.56 | 0.2 ± 3.08 | 0.2 ± 0.67 |
| Visit 5 (n=1221, 714, 188) | 0.1 ± 0.54 | 0.1 ± 0.28 | 0.3 ± 0.72 |
| Visit 6 (n=1170, 665, 208) | 0.1 ± 0.66 | 0.1 ± 0.33 | 0.1 ± 0.49 |
| Visit 7 (n=1111, 615, 219) | 0.1 ± 0.40 | 0.1 ± 0.43 | 0.2 ± 0.55 |
| Visit 8 (n=1099, 589, 233) | 0.1 ± 0.76 | 0.1 ± 0.42 | 0.1 ± 0.49 |
| Visit 9 (n=1046, 562, 229) | 0.1 ± 0.68 | 0.1 ± 0.50 | 0.1 ± 0.31 |
| Visit 10 (n=1031, 535, 235) | 0.1 ± 0.46 | 0.1 ± 0.42 | 0.1 ± 0.44 |
| Visit 11 (n=1006, 541, 248) | 0.1 ± 0.35 | 0.1 ± 2.59 | 0.1 ± 0.42 |
The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
| Days | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Baseline; n=657,418 ,0) | 12.2 ± 13.73 | 10.8 ± 10.93 | NA ± NA |
| Visit 2 (n=304,126, 33) | 14.4 ± 17.81 | 12.0 ± 14.26 | 13.0 ± 12.23 |
| Visit 3 (n=216, 58, 35) | 14.2 ± 16.83 | 9.4 ± 7.49 | 13.5 ± 13.65 |
| Visit 4 (n=151, 60, 24) | 12.6 ± 15.23 | 8.5 ± 11.87 | 9.1 ± 10.82 |
| Visit 5 (n=105, 35, 34) | 11.7 ± 13.02 | 9.8 ± 9.49 | 7.1 ± 6.21 |
| Visit 6 (n=107, 49, 19) | 10.8 ± 17.33 | 13.7 ± 27.34 | 18.3 ± 17.81 |
| Visit 7 (n=109, 45, 25) | 10.6 ± 14.41 | 10.2 ± 10.63 | 10.0 ± 11.33 |
| Visit 8 (n=98, 29, 23) | 9.5 ± 9.04 | 16.3 ± 15.52 | 14.7 ± 17.29 |
| Visit 9 (n=80, 38, 17) | 12.4 ± 14.44 | 6.9 ± 5.77 | 10.7 ± 17.20 |
| Visit 10 (n=85, 29, 27) | 10.1 ± 12.02 | 8.0 ± 5.41 | 9.0 ± 6.40 |
| Visit 11 (n=63, 19, 18) | 11.4 ± 13.24 | 8.7 ± 10.64 | 18.1 ± 31.57 |
The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.
| Surgical Procedures | Remicade | Standard Therapy | Switched to Remicade |
|---|---|---|---|
| Visit 1 (Basline; n=660, 419, 0) | 171 | 81 | NA |
| Visit 2 (n=304, 126, 33) | 135 | 51 | 7 |
| Visit 3 (n=217, 57, 36) | 121 | 23 | 12 |
| Visit 4 (n=153, 60, 24) | 68 | 16 | 8 |
| Visit 5 (n=106, 36, 34) | 50 | 14 | 14 |
| Visit 6 (n=108, 49, 19) | 49 | 21 | 11 |
| Visit 7 (n=109, 45, 25) | 48 | 20 | 6 |
| Visit 8 (n=98, 29, 23) | 43 | 12 | 7 |
| Visit 9 (n=82, 38, 17) | 38 | 13 | 8 |
| Visit 10 (n=85, 29, 27) | 38 | 13 | 8 |
| Visit 11 (n=63, 19, 18) | 34 | 6 | 8 |
Collected over Up to 5 Years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Therapy | — | 391/1,121 (34.9%) | 173/1,121 (15.4%) |
| Remicade | — | 792/1,541 (51.4%) | 441/1,541 (28.6%) |
| Switched to Remicade | — | 136/298 (45.6%) | 51/298 (17.1%) |
| Event | Standard Therapy | Remicade | Switched to Remicade |
|---|---|---|---|
| CROHN'S DISEASEGastrointestinal disorders | 131/1121 | 298/1541 | 47/298 |
| ANAL ABSCESSInfections and infestations | 17/1121 | 61/1541 | 8/298 |
| ANAL FISTULAGastrointestinal disorders | 11/1121 | 47/1541 | 4/298 |
| ABDOMINAL PAINGastrointestinal disorders | 29/1121 | 42/1541 | 9/298 |
| ILEAL STENOSISGastrointestinal disorders | 20/1121 | 41/1541 | 9/298 |
| INTESTINAL OBSTRUCTIONGastrointestinal disorders | 9/1121 | 36/1541 | 4/298 |
| SUBILEUSGastrointestinal disorders | 11/1121 | 17/1541 | 6/298 |
| EXPOSURE DURING PREGNANCYInjury, poisoning and procedural complications | 0/1121 | 1/1541 | 5/298 |
| DIARRHOEAGastrointestinal disorders | 6/1121 | 11/1541 | 4/298 |
| ILEUSGastrointestinal disorders | 12/1121 | 17/1541 | 4/298 |
| Event | Standard Therapy | Remicade | Switched to Remicade |
|---|---|---|---|
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 124/1121 | 281/1541 | 37/298 |
| CROHN'S DISEASEGastrointestinal disorders | 64/1121 | 153/1541 | 19/298 |
| ABDOMINAL PAINGastrointestinal disorders | 41/1121 | 100/1541 | 15/298 |
298 of the 1121 participants enrolled in the Standard Therapy Group switched to Remicade during follow-up. They are included in both the Standard Therapy and Switched to Remicade treatment groups, but baseline measures (obtained at the time of their switch to Remicade) are shown as separate rows in the Baseline Measures table.
| Age, Continuous(Years) | Remicade | Standard Therapy Group | Total |
|---|---|---|---|
| All Participants | 36.1 ± 12.90 | 37.5 ± 12.86 | 36.7 ± 12.90 |
| Switched to Remicade | NA ± NA | 36.7 ± 12.3 | 36.7 ± 12.3 |
| Sex/Gender, Customized(Participants) | Remicade | Standard Therapy Group | Total |
|---|---|---|---|
| Female (All Participants) | 935 | 677 | 1612 |
| Male (All Participants) | 606 | 444 | 1050 |
| Female (Switched to Remicade) | NA | 191 | NA |
| Male (Switched to Remicade) | NA | 107 | NA |
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