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Trial record 1 of 1 for:    SHP647-307
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Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307) (CARMEN CD 307)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627091
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Ontamalimab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 983 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : August 26, 2022
Estimated Study Completion Date : August 26, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Ontamalimab 25 mg
Participants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
Drug: Ontamalimab
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
Other Names:
  • SHP647
  • PF-00547659

Experimental: Ontamalimab 75 mg
Participants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
Drug: Ontamalimab
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
Other Names:
  • SHP647
  • PF-00547659

Placebo Comparator: Placebo
Participants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
Other: Placebo
SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.




Primary Outcome Measures :
  1. Number of Participants With Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

  2. Number of Participants With Enhanced Endoscopic Response at Week 52 [ Time Frame: Week 52 ]
    Enhanced endoscopic response is measured as a decrease from induction study baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.


Secondary Outcome Measures :
  1. Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) Less Than (<) 150 at Week 52 [ Time Frame: Week 52 ]
    Clinical remission is defined by Crohn's Disease Activity Index (CDAI) score which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.

  2. Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Glucocorticoid-free clinical remission is defined as clinical remission without requiring any treatment with glucocorticoids for at least 12 weeks prior to the Week 52. Number of participants with glucocorticoid-free clinical remission as measured by CDAI will be reported.

  3. Number of Participants With Clinical Remission as Defined by Crohn's Disease (CD) e-diary Subscores at Week 52 [ Time Frame: Week 52 ]
    Clinical remission at the Week 52 visit as defined by the following: CD daily e-diary subscores of average daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) over the 7 most recent days and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

  4. Number of Participants With Sustained Clinical Remission at Week 52 [ Time Frame: Baseline up to Week 52 ]
    Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with sustained remission, that is (ie), in remission at Week 52 visit, among participants who were in remission at the time of baseline.

  5. Number of Participants With Sustained Enhanced Endoscopic Response at Week 52 [ Time Frame: Baseline up to Week 52 ]
    Enhanced endoscopic response is measured as a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response at Week 52 visit, among participants who showed enhanced endoscopic response at the time of baseline will be reported.

  6. Number of Participants With Clinical Remission and Enhanced Endoscopic Response at Week 52 [ Time Frame: Week 52 ]
    Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Enhanced endoscopic response is measured as a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with clinical remission by 2-item PRO and enhanced endoscopic response at week 52 will be reported.

  7. Number of Participants With Complete Endoscopic Healing at Week 52 [ Time Frame: Week 52 ]
    Complete endoscopic healing is measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with complete endoscopic healing will be reported.

  8. Number of Participants With Clinical Response Over Time Based on 2-item PRO [ Time Frame: Baseline up to Week 52 ]
    Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.

  9. Number of Participants With Clinical Remission Over Time as Measured by 2-item PRO [ Time Frame: Baseline up to Week 52 ]
    Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission as defined by 2-item PRO over time will be reported.

  10. Number of Participants With Clinical Remission Over Time as Measured by Crohn's Disease Activity Index (CDAI) <150) [ Time Frame: Baseline up to Week 52 ]
    Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as defined by CDAI over time will be reported.

  11. Number of Participants With Sustained Clinical Remission Over Time as Measured by 2-item PRO [ Time Frame: Baseline up to Week 52 ]
    Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with sustained clinical remission as measured by 2-item PRO, ie, in remission at the time of baseline and each visit.

  12. Number of Participants With Sustained Clinical remission Over Time as Measured by Crohn's Disease Activity Index (CDAI) Less than (<) 150 [ Time Frame: Baseline up to Week 52 ]
    Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with sustained remission as measured by CDAI, ie, in remission at the time of baseline and each visit.

  13. Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 52 [ Time Frame: Baseline, Week 52 ]
    Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).

  14. Number of Participants With Clinical Response as Measured by At least 100-point Reduction in Crohn's Disease Activity Index (CDAI-100 response) Score [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease.

  15. Number of Participants With Clinical Response as Measured by At least 70-point Reduction in Crohn's Disease Activity Index (CDAI-70 response) Score [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    Clinical response as measured by at least 70-point reduction in CDAI score from baseline will be reported. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease.

  16. Number of Participants With Endoscopic Healing at Week 52 [ Time Frame: Week 52 ]
    Endoscopic healing measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic healing will be reported.

  17. Number of Participants With Sustained Endoscopic Healing at Week 52 [ Time Frame: Baseline up to Week 52 ]
    Endoscopic healing measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease). Individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with sustained endoscopic healing at week 52 ie, endoscopic healing at week 52 visit among participants who showed endoscopic healing at the time of baseline will be reported.

  18. Number of Participants With Sustained Complete Endoscopic Healing at Week 52 [ Time Frame: Baseline up to Week 52 ]
    Complete endoscopic healing is measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with sustained complete endoscopic healing at week 52 ie, complete endoscopic healing at week 52 visit among participants who showed complete endoscopic healing at the time of baseline.

  19. Change From Induction Study Baseline in Histology Scores at Week 52 as Assessed by Colonic Global Histologic Disease Score (CGHAS) [ Time Frame: Baseline, Week 52 ]
    Colonic Global Histologic Disease Score (CGHAS) uses scoring system for histological abnormalities in CD mucosal biopsy specimens. It includes different topics scored independently: epithelial damage (0=Normal - 2=Extensive pathology), architectural changes (0=Normal - 2=Severely disturbed), infiltration of mononuclear cells in the lamina propria (0=Normal - 2=Severe increase), infiltration of polymorphonuclear cells in the lamina propria (0=Normal - 2=Severe increase), polymorphonuclear cells in epithelium (1=In surface epithelium - 3=Crypt abscess), presence of erosion and/or ulcers (0=No, 1=Yes), presence of granuloma (0=No, 1=Yes) and number of biopsy specimens affected (0=None - 3=5 or 6).

  20. Change From Induction Study Baseline in Histology Scores at Week 52 as Assessed by Ileal Global Histologic Disease Score (IGHAS) [ Time Frame: Baseline, Week 52 ]
    Ileal Global Histologic Disease Score (IGHAS) uses scoring system for histological abnormalities in CD mucosal biopsy specimens. It includes different topics scored independently: epithelial damage (0=Normal - 2=Extensive pathology), architectural changes (0=Normal - 2=Severely disturbed), infiltration of mononuclear cells in the lamina propria (0=Normal - 2=Severe increase), infiltration of polymorphonuclear cells in the lamina propria (0=Normal - 2=Severe increase), polymorphonuclear cells in epithelium (1=In surface epithelium - 3=Crypt abscess), presence of erosion and/or ulcers (0=No, 1=Yes), presence of granuloma (0=No, 1=Yes) and number of biopsy specimens affected (0=None - 3=5 or 6).

  21. Change From Induction Study Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Scores [ Time Frame: Baseline, Week 12, Week 24 and Week 52, or early termination ]
    The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life.

  22. Change From Induction Study Baseline in Short Form-36 Health Survey (SF-36) at Week 52 [ Time Frame: Baseline, Week 52 ]
    The Short form-36 health survey is used to assess health-related quality of life (HRQL). It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

  23. Incidence of Hospitalizations [ Time Frame: Baseline up to Week 68 ]
    Incidence of hospitalizations will be assessed.

  24. Incidence of Total Inpatient Days [ Time Frame: Baseline up to Week 68 ]
    Incidence of total inpatient days will be assessed.

  25. Incidence of Crohn's Disease (CD)-related and Other Surgeries [ Time Frame: Baseline up to Week 68 ]
    Incidence of Crohn's disease-related surgeries and other surgical procedures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.
  • Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:

    a) Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or b) Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline: i) Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO subscores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

ii) A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.

iii) A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

iv) A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.

*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.

- Participants receiving any treatments for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

  • Participants who had major protocol deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
  • Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male participants) through the conclusion of study participation.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
  • Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
  • Participants who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
  • Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg,] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
  • Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
  • Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrolment in Study SHP647-307.

    1. Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).
    2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.
    3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
    4. Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).
    5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).
    6. Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)
    7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

      • Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
  • Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
  • Participants who are participating in other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627091


Contacts
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Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03627091    
Other Study ID Numbers: SHP647-307
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shire:
Crohn's disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases