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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020137-10 | EudraCT Number |
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The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein [hs-CRP] and fecal calprotectin), and corticosteroid use, improves the rate of mucosal healing 48 weeks after randomization compared with management using less stringent criteria based only on CDAI and corticosteroid use.
The study included a 1- to 3-week screening period, up to 8 weeks of prednisone run-in treatment, a 48-week post-randomization treatment period, and a 70 day follow-up phone call or clinic visit, for a total duration of up to 69 weeks.
Participants who met entry criteria were enrolled and initiated an oral prednisone regimen at Baseline (Week 0). At the first key visit, participants were randomized into 1 of 2 groups (Tight Control group or Clinically Driven group), with stratification according to screening smoking status, weight, and disease duration.
The first key visit was the randomization visit; subsequent key visits occurred every 12 weeks following the first key visit. Randomization normally took place 9 weeks after Baseline. However, participants who fulfilled the early randomization criteria may have been randomized as early as the Baseline (Week 0) visit. Therapeutic option changes, if appropriate, occurred at key visits based on results from previous success criteria visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tight Control Management | Experimental | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab. Therapy was escalated according to pre-specified tight control criteria: At Key Visit 1 the success criteria were CDAI < 150, hs-CRP, < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone use. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria were CDAI < 150, hs-CRP < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone during the preceding week. |
|
| Clinically Driven Management | Active Comparator | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab. Therapy was escalated according to pre-specified failure criteria using less stringent criteria: At Key Visit 1 the criteria for management of disease activity were a CDAI decrease ≥ 70 (CR-70) compared to Baseline or CDAI < 200 at 1 week prior to the visit. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria for a change in treatment were a CDAI decrease of ≥ 100 (CR-100) compared to Baseline or CDAI < 200, and absence of prednisone during the preceding week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | If adalimumab was initiated, it was administered subcutaneously as a 160 mg induction dose the first week, followed by 80 mg 2 weeks later, followed by 40 mg every other week as a maintenance dose. The dose of adalimumab was increased from 40 mg eow to 40 mg every week in participants with an inadequate response and de-escalated to 40 mg eow in participants who met success criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Mucosal Healing and No Deep Ulcerations | Percentage of participants with mucosal healing (defined as Crohn's disease endoscopy Index of severity [CDEIS] < 4) and no deep ulcerations on ileocolonoscopy (defined as the absence of all deep ulcerations in all segments explored in CDEIS) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing data 48 weeks after Randomization were counted as non-responders. | 48 weeks after Randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Deep Remission 48 Weeks After Randomization | Deep remission was defined as CDAI < 150, discontinuation from steroids for at least 8 weeks, absence of draining fistula, CDEIS < 4 and no deep ulcerations. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing data 48 weeks after randomization were counted as non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Robinson, Pharm.D. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35919766 | Derived | Lakatos PL, Kaplan GG, Bressler B, Khanna R, Targownik L, Jones J, Rahal Y, McHugh K, Panaccione R. Cost-Effectiveness of Tight Control for Crohn's Disease With Adalimumab-Based Treatment: Economic Evaluation of the CALM Trial From a Canadian Perspective. J Can Assoc Gastroenterol. 2022 Mar 10;5(4):169-176. doi: 10.1093/jcag/gwac001. eCollection 2022 Aug. | |
| 32224129 |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 252 participants were enrolled and received study treatment, of whom
165 entered the prednisone run-in
87 randomized at Baseline.
Randomization was stratified by smoking status, weight, and disease duration.
This study was conducted at 59 sites in Canada, European Union, Israel, Japan, Russia, South Africa, Switzerland, Turkey, and the Ukraine.
The study included a screening period, up to 8 weeks of prednisone run-in treatment, a 48-week post-randomization treatment period, and a 70 day follow-up phone call or clinic visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinically Driven Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab. Therapy was escalated according to pre-specified failure criteria using less stringent criteria: At Key Visit 1 the criteria for management of disease activity were a CDAI decrease ≥ 70 (CR-70) compared to Baseline or CDAI < 200 at 1 week prior to the visit. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria for a change in treatment were a CDAI decrease of ≥ 100 (CR-100) compared to Baseline or CDAI < 200, and absence of prednisone during the preceding week. |
| FG001 | Tight Control Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. Participants who randomized at Week 9 meeting success criteria started with no therapy; participants who randomized prior to Week 9 or who randomized at Week 9 but did not meet the success criteria began treatment with adalimumab. Therapy was escalated according to pre-specified tight control criteria: At Key Visit 1 the success criteria were CDAI < 150, hs-CRP, < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone use. At Key Visits 3, 4, and 5 (every 12 weeks after Key visit 1), the criteria were CDAI < 150, hs-CRP < 5 mg/L, fecal calprotectin < 250 μg/g, and absence of prednisone during the preceding week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinically Driven Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Mucosal Healing and No Deep Ulcerations | Percentage of participants with mucosal healing (defined as Crohn's disease endoscopy Index of severity [CDEIS] < 4) and no deep ulcerations on ileocolonoscopy (defined as the absence of all deep ulcerations in all segments explored in CDEIS) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing data 48 weeks after Randomization were counted as non-responders. | All randomized participants; Participants with missing CDEIS values from endoscopies performed 48 weeks after randomization were imputed as non-responders. | Posted | Number | percentage of participants | 48 weeks after Randomization |
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from randomization until 70 days after the last dose of study drug (up to 58 weeks).
TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity on or after randomization until 70 days after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinically Driven Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D011241 | Prednisone |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Prednisone | Drug | The suggested regimen for participants initiating prednisone consisted of a maximum dose of prednisone 40 mg/day for 2 weeks, followed by a fixed taper for 6 weeks. |
|
| Azathioprine | Drug | Participants with normal thiopurine methyltransferase (TPMT) enzyme activity could receive oral azathioprine 2.5 mg/kg/day. In participants with intermediate TPMT enzyme activity azathioprine was initiated at a dose of 1.25 mg/kg/day. The dose of azathioprine was adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine. |
|
| 48 weeks after Randomization |
| Percentage of Participants in Biologic Remission 48 Weeks After Randomization | Biologic remission was defined as high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, fecal Calprotectin < 250 μg/g, and CDEIS < 4 at 48 weeks after randomization. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after Randomization were counted as non-responders. | 48 weeks after Randomization |
| Percentage of Participants With Mucosal Healing 48 Weeks After Randomization | Percentage of participants with mucosal healing (defined as a CDEIS < 4) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after Randomization were counted as non-responders. | 48 weeks after Randomization |
| Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization | Percentage of participants with mucosal healing (defined as CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization. The ileocolonoscopies were evaluated by the site. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after randomization were counted as non-responders. | 48 weeks after Randomization |
| Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization | Complete mucosal healing was defined as CDEIS = 0. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after randomization were counted as non-responders. | 48 weeks after Randomization |
| Percentage of Participants With Endoscopic Response 48 Weeks After Randomization | Endoscopic response was defined as a decrease CDEIS > 5 points. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after Randomization were counted as non-responders. | 48 weeks after Randomization |
| Change From Baseline in CDEIS at 48 Weeks After Randomization | CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. A negative change from Baseline indicates improvement. | Baseline and 48 weeks after Randomization |
| Change From Baseline in CDAI Over Time | The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from Baseline indicates improvement. | Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization. |
| Time to Crohn's Disease Flare | Time to Crohn's disease flare, where flare is defined as an increase in CDAI ≥ 70 points compared to Week 8 or Early Randomization CDAI, and a CDAI > 220. | From Randomization to 48 weeks after Randomization |
| Time to Clinical Remission | Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI scores generally range from 0 to 600 where higher scores indicate more severe disease. | From Randomization through 48 weeks after Randomization |
| Time to Steroid-free Remission | Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. | From Randomization through 48 weeks after Randomization |
| Percentage of Participants in Clinical Remission Over Time | Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. Participants with missing data at each time point were counted as non-responders. | Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization. |
| Percentage of Participants in Steroid-free Remission Over Time | Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. Participants with missing data at each time point were counted as non-responders. | 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization. |
| Time to All-cause Hospitalization | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. | From Randomization through 48 weeks after Randomization |
| Time to Crohn's Disease-related Hospitalization or Hospitalization Due to Adverse Event Relating to Study Medication | Crohn's disease-related hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic for reasons related to Crohn's disease (CD). Hospitalization for adverse events relating to study medication, i.e., prednisone, azathioprine or adalimumab, were according to Investigator's clinical judgment. | From Randomization through 48 weeks after Randomization |
| Number of Major Crohn's Disease-related Surgeries After Randomization | Major Crohn's disease-related intra-abdominal surgery included:
The following were excluded:
| From Randomization through 48 weeks after Randomization |
| Number of Crohn's Disease-related Hospitalizations After Randomization | Any hospitalization with an overnight stay in hospital/clinic related to Crohn's disease. | From Randomization through 48 weeks after Randomization |
| Number of All-cause Hospitalizations After Randomization | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. | From Randomization through 48 weeks after Randomization |
| Total Length of Stay in Hospital for All-cause Hospitalizations | From Randomization through 48 weeks after Randomization |
| Total Length of Stay in Hospital for Crohn's Disease-related Hospitalizations | From Randomization through 48 weeks after Randomization |
| Number of Crohn's Disease-related Surgical Procedures After Randomization | The total number of CD-related surgical procedures included major CD-related surgery, debridement, perineal related surgery - abscess drainage, seton placement, fistulotomy, and TPN. | From Randomization through 48 weeks after Randomization |
| Time to Crohn's Disease-related Hospitalization Due to Emergency | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department. | From Randomization through 48 weeks after Randomization |
| Number of Crohn's Disease-related Hospitalizations Due to Emergency | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department. | From Randomization through 48 weeks after Randomization |
| Change in Crohn's Disease Behavior According to Montreal Classification | Participants' Crohn's Disease was classified according to the Montreal Classification which classifies CD according to its predominant phenotypic elements (age at diagnosis, location, and disease behavior) based on the results of clinical examination and endoscopy. Disease behavior was classified according to the following: B1 = non-stricturing, non-penetrating; B2 = structuring; B3 = penetrating; P = perianal disease modifier. The change in Montreal Classification is presented in three categories: no change, deterioration, and improvement. Deterioration was defined as an increase in behavior index between 1 and 3, or development of perianal disease. Participants with missing data at Week 48 were classified as deterioration. | From Baseline to 48 weeks after Randomization |
| Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time | High sensitivity C-reactive protein was analyzed by a central laboratory. | Baseline and 8 weeks during the prednisone run-in, and 11, 23, 35, and 48 weeks after Randomization. |
| Change in Fecal Calprotectin From Baseline to 48 Weeks After Randomization | Stool samples were analyzed by a central laboratory for fecal calprotectin qualitative measurement (< 250 or ≥ 250 μg/g). Results are reported for participants in each category at Baseline and 48 weeks after Randomization. Participants with missing data 48 weeks after Randomization were counted as having fecal calprotectin ≥ 250µg/g. | Baseline and 48 weeks after Randomization |
| Total Dose of Prednisone | The total dose of prednisone each participant received during both the run-in phase and post-randomization treatment phase. | From Baseline through 48 weeks after Randomization |
| Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | The IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease, feeling in general, and mood. Each question is answered on a scale from 1 (all of the time) to 7 ( none of the time); the total score ranges from 7 (worst) to 224 (best). A positive change from baseline indicates improvement. | Baseline and 48 weeks after Randomization |
| Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD) | The WPAI:CD questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Work time missed was defined as the percentage of time absent from work due to Crohn's disease in the past week. Impairment while working is the participant's assessment of the degree to which Crohn's disease affected productivity while working in the past 7 days. Total work productivity impairment takes into account both hours missed due to Crohn's disease symptoms and the patient's assessment of the degree to which Crohn's disease affected their productivity while working. Total activity impairment is the percent impairment of non-work related activities due to Crohn's disease. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. | Baseline and 48 weeks after Randomization |
| Change From Baseline in Patient Health Questionnaire - 9 (PHQ9) | The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression. A negative change from Baseline score indicates improvement. | Baseline and 48 weeks after Randomization |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score | The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, from 0 (not at all) to 4 (very much). The FACIT-Fatigue score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement. . | Baseline and 48 weeks after Randomization |
| Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores | The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. The mental component summary (MCS) score summarizes the subscales vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement. | Baseline and 48 weeks after Randomization |
| Ungaro RC, Yzet C, Bossuyt P, Baert FJ, Vanasek T, D'Haens GR, Joustra VW, Panaccione R, Novacek G, Reinisch W, Armuzzi A, Golovchenko O, Prymak O, Goldis A, Travis SP, Hebuterne X, Ferrante M, Rogler G, Fumery M, Danese S, Rydzewska G, Pariente B, Hertervig E, Stanciu C, Serrero M, Diculescu M, Peyrin-Biroulet L, Laharie D, Wright JP, Gomollon F, Gubonina I, Schreiber S, Motoya S, Hellstrom PM, Halfvarson J, Butler JW, Petersson J, Petralia F, Colombel JF. Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease. Gastroenterology. 2020 Jul;159(1):139-147. doi: 10.1053/j.gastro.2020.03.039. Epub 2020 Mar 26. |
| 31285357 | Derived | Panaccione R, Colombel JF, Travis SPL, Bossuyt P, Baert F, Vanasek T, Danalioglu A, Novacek G, Armuzzi A, Reinisch W, Johnson S, Buessing M, Neimark E, Petersson J, Lee WJ, D'Haens GR. Tight control for Crohn's disease with adalimumab-based treatment is cost-effective: an economic assessment of the CALM trial. Gut. 2020 Apr;69(4):658-664. doi: 10.1136/gutjnl-2019-318256. Epub 2019 Jul 8. |
| 29096949 | Derived | Colombel JF, Panaccione R, Bossuyt P, Lukas M, Baert F, Vanasek T, Danalioglu A, Novacek G, Armuzzi A, Hebuterne X, Travis S, Danese S, Reinisch W, Sandborn WJ, Rutgeerts P, Hommes D, Schreiber S, Neimark E, Huang B, Zhou Q, Mendez P, Petersson J, Wallace K, Robinson AM, Thakkar RB, D'Haens G. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017 Dec 23;390(10114):2779-2789. doi: 10.1016/S0140-6736(17)32641-7. Epub 2017 Oct 31. |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Miscellaneous |
|
| Tight Control Management |
Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Count of Participants | Participants |
|
| Current Tobacco Use | Count of Participants | Participants |
|
| Disease Duration | Count of Participants | Participants |
|
| Crohn's Disease Endoscopy Index of Severity (CDEIS) | CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. | Mean | Standard Deviation | units on a scale |
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| Crohn's Disease Activity Index (CDAI) | CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications, the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where higher scores indicate more severe disease. | Mean | Standard Deviation | units on a scale |
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| ID | Title | Description |
|---|
| OG000 | Clinically Driven Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI) and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. |
| OG001 | Tight Control Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. |
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| Secondary | Percentage of Participants in Deep Remission 48 Weeks After Randomization | Deep remission was defined as CDAI < 150, discontinuation from steroids for at least 8 weeks, absence of draining fistula, CDEIS < 4 and no deep ulcerations. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing data 48 weeks after randomization were counted as non-responders. | All randomized participants; non-responder imputation was used. | Posted | Number | percentage of participants | 48 weeks after Randomization |
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| Secondary | Percentage of Participants in Biologic Remission 48 Weeks After Randomization | Biologic remission was defined as high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, fecal Calprotectin < 250 μg/g, and CDEIS < 4 at 48 weeks after randomization. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after Randomization were counted as non-responders. | All randomized participants; non-responder imputation was used. | Posted | Number | percentage of participants | 48 weeks after Randomization |
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| Secondary | Percentage of Participants With Mucosal Healing 48 Weeks After Randomization | Percentage of participants with mucosal healing (defined as a CDEIS < 4) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after Randomization were counted as non-responders. | All randomized participants; non-responder imputation was used. | Posted | Number | percentage of participants | 48 weeks after Randomization |
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| Secondary | Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization | Percentage of participants with mucosal healing (defined as CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization. The ileocolonoscopies were evaluated by the site. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after randomization were counted as non-responders. | All randomized participants; non-responder imputation was used. | Posted | Number | percentage of participants | 48 weeks after Randomization |
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| Secondary | Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization | Complete mucosal healing was defined as CDEIS = 0. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after randomization were counted as non-responders. | All randomized participants; non-responder imputation was used. | Posted | Number | percentage of participants | 48 weeks after Randomization |
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| Secondary | Percentage of Participants With Endoscopic Response 48 Weeks After Randomization | Endoscopic response was defined as a decrease CDEIS > 5 points. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity. Participants with missing values 48 weeks after Randomization were counted as non-responders. | All randomized participants; non-responder imputation was used. | Posted | Number | percentage of participants | 48 weeks after Randomization |
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| Secondary | Change From Baseline in CDEIS at 48 Weeks After Randomization | CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. A negative change from Baseline indicates improvement. | Randomized participants with non-missing data at Baseline and 48 weeks after Randomization. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 weeks after Randomization |
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| Secondary | Change From Baseline in CDAI Over Time | The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from Baseline indicates improvement. | Randomized participants with non-missing data at each time point. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization. |
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| Secondary | Time to Crohn's Disease Flare | Time to Crohn's disease flare, where flare is defined as an increase in CDAI ≥ 70 points compared to Week 8 or Early Randomization CDAI, and a CDAI > 220. | Randomized participants | Posted | Median | Inter-Quartile Range | days | From Randomization to 48 weeks after Randomization |
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| Secondary | Time to Clinical Remission | Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI scores generally range from 0 to 600 where higher scores indicate more severe disease. | Randomized participants | Posted | Median | Inter-Quartile Range | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Time to Steroid-free Remission | Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. | Randomized participants | Posted | Median | Inter-Quartile Range | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Percentage of Participants in Clinical Remission Over Time | Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. Participants with missing data at each time point were counted as non-responders. | Randomized participants; non-responder imputation was used. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment. | Posted | Number | percentage of participants | Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization. |
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| Secondary | Percentage of Participants in Steroid-free Remission Over Time | Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. Participants with missing data at each time point were counted as non-responders. | Randomized participants; non-responder imputation was used. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment. | Posted | Number | percentage of participants | 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization. |
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| Secondary | Time to All-cause Hospitalization | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. | Randomized participants | Posted | Median | Inter-Quartile Range | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Time to Crohn's Disease-related Hospitalization or Hospitalization Due to Adverse Event Relating to Study Medication | Crohn's disease-related hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic for reasons related to Crohn's disease (CD). Hospitalization for adverse events relating to study medication, i.e., prednisone, azathioprine or adalimumab, were according to Investigator's clinical judgment. | Randomized participants | Posted | Median | Inter-Quartile Range | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Number of Major Crohn's Disease-related Surgeries After Randomization | Major Crohn's disease-related intra-abdominal surgery included:
The following were excluded:
| All randomized participants | Posted | Number | surgeries | From Randomization through 48 weeks after Randomization |
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| Secondary | Number of Crohn's Disease-related Hospitalizations After Randomization | Any hospitalization with an overnight stay in hospital/clinic related to Crohn's disease. | All randomized participants | Posted | Number | hospitalizations | From Randomization through 48 weeks after Randomization |
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| Secondary | Number of All-cause Hospitalizations After Randomization | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. | All randomized participants | Posted | Number | hospitalizations | From Randomization through 48 weeks after Randomization |
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| Secondary | Total Length of Stay in Hospital for All-cause Hospitalizations | Randomized participants with all-cause hospitalizations | Posted | Mean | Standard Deviation | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Total Length of Stay in Hospital for Crohn's Disease-related Hospitalizations | Randomized participants with Crohn's disease-related hospitalizations | Posted | Mean | Standard Deviation | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Number of Crohn's Disease-related Surgical Procedures After Randomization | The total number of CD-related surgical procedures included major CD-related surgery, debridement, perineal related surgery - abscess drainage, seton placement, fistulotomy, and TPN. | All randomized participants | Posted | Number | surgical procedures | From Randomization through 48 weeks after Randomization |
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| Secondary | Time to Crohn's Disease-related Hospitalization Due to Emergency | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department. | Randomized participants | Posted | Median | Inter-Quartile Range | days | From Randomization through 48 weeks after Randomization |
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| Secondary | Number of Crohn's Disease-related Hospitalizations Due to Emergency | Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department. | All randomized participants | Posted | Number | emergency hospitalizations | From Randomization through 48 weeks after Randomization |
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| Secondary | Change in Crohn's Disease Behavior According to Montreal Classification | Participants' Crohn's Disease was classified according to the Montreal Classification which classifies CD according to its predominant phenotypic elements (age at diagnosis, location, and disease behavior) based on the results of clinical examination and endoscopy. Disease behavior was classified according to the following: B1 = non-stricturing, non-penetrating; B2 = structuring; B3 = penetrating; P = perianal disease modifier. The change in Montreal Classification is presented in three categories: no change, deterioration, and improvement. Deterioration was defined as an increase in behavior index between 1 and 3, or development of perianal disease. Participants with missing data at Week 48 were classified as deterioration. | All randomized participants; non-responder imputation was used. | Posted | Count of Participants | Participants | From Baseline to 48 weeks after Randomization |
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| Secondary | Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time | High sensitivity C-reactive protein was analyzed by a central laboratory. | Randomized participants; last observation carried forward imputation was used. | Posted | Mean | Standard Deviation | mg/L | Baseline and 8 weeks during the prednisone run-in, and 11, 23, 35, and 48 weeks after Randomization. |
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| Secondary | Change in Fecal Calprotectin From Baseline to 48 Weeks After Randomization | Stool samples were analyzed by a central laboratory for fecal calprotectin qualitative measurement (< 250 or ≥ 250 μg/g). Results are reported for participants in each category at Baseline and 48 weeks after Randomization. Participants with missing data 48 weeks after Randomization were counted as having fecal calprotectin ≥ 250µg/g. | Randomized participants with Baseline data; non-responder imputation was used. | Posted | Count of Participants | Participants | Baseline and 48 weeks after Randomization |
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| Secondary | Total Dose of Prednisone | The total dose of prednisone each participant received during both the run-in phase and post-randomization treatment phase. | Participants who received prednisone | Posted | Mean | Standard Deviation | mg | From Baseline through 48 weeks after Randomization |
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| Secondary | Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | The IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease, feeling in general, and mood. Each question is answered on a scale from 1 (all of the time) to 7 ( none of the time); the total score ranges from 7 (worst) to 224 (best). A positive change from baseline indicates improvement. | Randomized participants with baseline and at least one post-baseline value; last observation carried forward imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 weeks after Randomization |
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| Secondary | Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD) | The WPAI:CD questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Work time missed was defined as the percentage of time absent from work due to Crohn's disease in the past week. Impairment while working is the participant's assessment of the degree to which Crohn's disease affected productivity while working in the past 7 days. Total work productivity impairment takes into account both hours missed due to Crohn's disease symptoms and the patient's assessment of the degree to which Crohn's disease affected their productivity while working. Total activity impairment is the percent impairment of non-work related activities due to Crohn's disease. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement. | Randomized participants with baseline and at least one post-baseline value; last observation carried forward imputation was used. The first 3 scores were only calculated for participants who were employed. | Posted | Mean | Standard Deviation | percent impairment | Baseline and 48 weeks after Randomization |
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| Secondary | Change From Baseline in Patient Health Questionnaire - 9 (PHQ9) | The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression. A negative change from Baseline score indicates improvement. | Randomized participants with Baseline and at least one post-baseline value; last observation carried forward imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 weeks after Randomization |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score | The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, from 0 (not at all) to 4 (very much). The FACIT-Fatigue score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement. . | Randomized participants with Baseline and at least 1 post-baseline value; last observation carried forward imputation was used | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 weeks after Randomization |
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| Secondary | Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores | The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. The mental component summary (MCS) score summarizes the subscales vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement. | Randomized participants with Baseline and at least one post-baseline value; last observation carried forward imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 weeks after Randomization |
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| 25 |
| 122 |
| 78 |
| 122 |
| EG001 | Tight Control Management | Participants randomized to receive management of disease activity using criteria based on Crohn's Disease Activity Index (CDAI), high sensitivity C-reactive protein (hs-CRP), fecal calprotectin, and corticosteroid use. Participants received customized therapy that could include prednisone, adalimumab, and azathioprine. | 22 | 122 | 76 | 122 |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ANAL FISTULA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| FISTULA OF SMALL INTESTINE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ILEAL STENOSIS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ILEUS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| MALOCCLUSION | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| PERITONEAL PERFORATION | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| SUBILEUS | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| DRUG INTOLERANCE | General disorders | MedDRA (19.0) | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
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| ABDOMINAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| ANAL ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| GASTROENTERITIS SALMONELLA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| NASAL VESTIBULITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| ROTAVIRUS INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| VIRAEMIA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| CARTILAGE INJURY | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
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| RETROGNATHIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| INTRACRANIAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| NASAL SEPTUM DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (19.0) | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA (19.0) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (19.0) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| 42 Weeks After Randomization |
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|
| 48 Weeks After Randomization |
|
|
| 2 Weeks After Randomization |
|
| 6 Weeks After Randomization |
|
| 11 Weeks After Randomization |
|
| 14 Weeks After Randomization |
|
| 18 Weeks After Randomization |
|
| 23 Weeks After Randomization |
|
| 26 Weeks After Randomization |
|
| 30 Weeks After Randomization |
|
| 35 Weeks After Randomization |
|
| 38 Weeks After Randomization |
|
| 42 Weeks After Randomization |
|
| 48 Weeks After Randomization |
|
| 18 Weeks After Randomization |
|
| 23 Weeks After Randomization |
|
| 26 Weeks After Randomization |
|
| 30 Weeks After Randomization |
|
| 35 Weeks After Randomization |
|
| 38 Weeks After Randomization |
|
| 42 Weeks After Randomization |
|
| 48 Weeks After Randomization |
|
| Improvement |
|
| 11 Weeks After Randomization |
|
|
| 23 Weeks After Randomization |
|
|
| 35 Weeks After Randomization |
|
|
| 48 Weeks After Randomization |
|
|
| Baseline ≥ 250µg/g and Week 48 < 250µg/g |
|
| Baseline ≥ 250µg/g and Week 48 ≥ 250µg/g |
|
| Impairment while working |
|
|
| Overall work impairment |
|
|
| Activity impairment |
|
|