Crohn's DiseaseNCT02619552
Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
An observational study of Crohn's Disease and IBD, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, IBD
- What is being tested?
- Anti-TNF and Steroids
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators are planning a study with 60 experimental participants and 30 control participants. The investigators will recruit participants from multiple referral centers for IBD with an existing population of nearly 5,000 patients.
Who may be able to join
- Diagnosis of Crohn's disease confirmed by standard criteria
- Active luminal Crohn's disease defined by an HBI score of >4 or with draining perianal Crohn's disease a) Active perianal Crohn's disease defined a presence of draining perianal fistula on physical exam19
- Patients with active luminal Crohn's disease must be initiating treatment with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi) or a steroid (prednisone, Entocort, or Uceris).
- Patients with active perianal disease must be initiating therapy with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi).
- Can understand written instructions in English
Who cannot join
- Previous primary non-response to an anti-TNF
- Uncontrolled medical or psychiatric disease (a. Degenerative neurologic condition, b.Unstable angina, c.Class III/IV congestive heart failure, d.Severe asthma or chronic obstructive pulmonary disease, e.Symptomatic peripheral vascular disease, f. Chronic renal insufficiency (creatinine > 2.0), g. Malignancy within the last 3 years (excluding squamous or basal cell cancers of the skin), h. Poorly controlled depression, mania, and schizophrenia, i. Active infection, j. Acquired immunodeficiency syndrome)
- Inability to adhere to the protocol
- Need for imminent surgery other than an exam under anesthesia
- Under 18 years of age.
- Pregnancy
- Use of concurrent prednisone >30 mg per day in the anti-TNF groups
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mercy Medical Center
Baltimore, Maryland, 21201
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Penn State Hershey Medical Center
Hershey, Pennsylvania
Vanderbilt University
Nashville, Tennessee
About this study
Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects.
Previous studies have shown that sexual function is impaired in patients with Crohn's disease. It is likely that both the symptoms related to the disease, medications used to treat the disease, and surgery all impair sexual function in a variety of ways. For example, body image may be impaired, patients may be worried about bowel incontinence or unpleasant odors associated with diarrhea, patients may have significant pelvic pain secondary to perianal fistulas, or they may have painful intercourse from adjacent inflammation or scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual function is not known.
Read more
The investigators propose a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids.
The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.
- Conditions
- Crohn's Disease, IBD
- Being tested
- Anti-TNF, Steroids
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNFDrug
Also called Remicade, Humira, Cimzia
All participants in this arm receive an anti-TNF for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Anti-TNFDrug
Also called Remicade, Humira, Cimzia
All participants in this arm receive an anti-TNF for the treatment of perianal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
SteroidsDrug
Also called Prednisone, Budesonide
All participants in this arm receive steroids for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF (Remicade, Humira or Cimzia) for luminal CD | All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. Receives: Drug: Anti-TNF | |
| Anti-TNF (Remicade, Humira or Cimzia)for perianal CD | All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. Receives: Drug: Anti-TNF | |
| Steroid (Prednisone or budesonide) for luminal CD | All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. Receives: Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Sexual Function
Sexual Function Questionnaire
Measured: 6 months
Assessment of Disease Activity
Harvey Bradshaw Index
Measured: 6 months
Assessment of Quality of Life
Short Inflammatory Bowel Disease Questionnaire
Measured: 6 months
Assessment of Body Image
Body Image Scale
Measured: 6 months
Assessment of Depression
PHQ 9
Measured: 6 months
Assessment of Perianal Disease Activity
Perianal Disease Activity Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startAug 2011
- Primary completionJun 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, Milton S. Hershey Medical Center, Mercy Medical Center
- Responsible party
- Principal investigator, Raymond Cross, University of Maryland, Baltimore
- Investigators
- Raymond Cross, MD, MS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619552
- Sponsor's protocol ID
- HP-00050472
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2015
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02619552
- Acronym / sponsor ID
- HP-00050472
- Conditions
- Crohn's Disease, IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Vanderbilt University, Milton S. Hershey Medical Center, Mercy Medical Center
- Study start
- Aug 2011 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects.
Previous studies have shown that sexual function is impaired in patients with Crohn's disease. It is likely that both the symptoms related to the disease, medications used to treat the disease, and surgery all impair sexual function in a variety of ways. For example, body image may be impaired, patients may be worried about bowel incontinence or unpleasant odors associated with diarrhea, patients may have significant pelvic pain secondary to perianal fistulas, or they may have painful intercourse from adjacent inflammation or scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual function is not known.
The investigators propose a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids.
The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF (Remicade, Humira or Cimzia) for luminal CD | – | Drug: Anti-TNFAll participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. |
| Anti-TNF (Remicade, Humira or Cimzia)for perianal CD | – | Drug: Anti-TNFAll participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. |
| Steroid (Prednisone or budesonide) for luminal CD | – | Drug: SteroidsAll participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators are planning a study with 60 experimental participants and 30 control participants. The investigators will recruit participants from multiple referral centers for IBD with an existing population of nearly 5,000 patients.
Key inclusion criteria (5 listed)
- Diagnosis of Crohn's disease confirmed by standard criteria
- Active luminal Crohn's disease defined by an HBI score of >4 or with draining perianal Crohn's disease a) Active perianal Crohn's disease defined a presence of draining perianal fistula on physical exam19
- Patients with active luminal Crohn's disease must be initiating treatment with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi) or a steroid (prednisone, Entocort, or Uceris).
- Patients with active perianal disease must be initiating therapy with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi).
- Can understand written instructions in English
Key exclusion criteria (7 listed)
- Previous primary non-response to an anti-TNF
- Uncontrolled medical or psychiatric disease (a. Degenerative neurologic condition, b.Unstable angina, c.Class III/IV congestive heart failure, d.Severe asthma or chronic obstructive pulmonary disease, e.Symptomatic peripheral vascular disease, f. Chronic renal insufficiency (creatinine > 2.0), g. Malignancy within the last 3 years (excluding squamous or basal cell cancers of the skin), h. Poorly controlled depression, mania, and schizophrenia, i. Active infection, j. Acquired immunodeficiency syndrome)
- Inability to adhere to the protocol
- Need for imminent surgery other than an exam under anesthesia
- Under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-TNFAlso: Remicade, Humira, CimziaAll participants in this arm receive an anti-TNF for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. | Drug | Anti-TNF (Remicade, Humira or Cimzia) for luminal CD |
| Anti-TNFAlso: Remicade, Humira, CimziaAll participants in this arm receive an anti-TNF for the treatment of perianal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. | Drug | Anti-TNF (Remicade, Humira or Cimzia)for perianal CD |
| SteroidsAlso: Prednisone, BudesonideAll participants in this arm receive steroids for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study. | Drug | Steroid (Prednisone or budesonide) for luminal CD |
Primary outcome
Assessment of Sexual Function
Time frame: 6 months
Sexual Function Questionnaire
Assessment of Disease Activity
Time frame: 6 months
Harvey Bradshaw Index
Assessment of Quality of Life
Time frame: 6 months
Short Inflammatory Bowel Disease Questionnaire
Assessment of Body Image
Time frame: 6 months
Body Image Scale
Assessment of Depression
Time frame: 6 months
PHQ 9
Assessment of Perianal Disease Activity
Time frame: 6 months
Perianal Disease Activity Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Cross, MD, MS principal investigator
University of Maryland, Baltimore
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and IBD, run by University of Maryland, Baltimore at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Sexual Function (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.