Crohn's DiseasePhase 2NCT00221026
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
A Phase 2 study testing Methoxsalen +ECP and Extracorporeal Photopheresis in people with Crohn's Disease, run by Mallinckrodt at 15 sites in 4 countries.
Trial summary
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Methoxsalen +ECP and Extracorporeal Photopheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Dec 2004to Jun 2006
- Phase
- Phase 2
- 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
Who may be able to join
- Signed and dated informed consent must be obtained prior to conducting any study procedure.
- Patients must be greater than or equal to 18 years of age.
- Patients must have a body weight greater than or equal to 40 kg (88 lb).
- Patients must have had Crohn's disease for at least 6 months duration (with colitis, ileitis, or ileocolitis) confirmed by radiography or endoscopy.
- Patients must have a CDAI greater than or equal to 220 to < 450.
- Patients must have a CRP concentration > 10.0 mg/L (1.0 mg/dL) or evidence of active inflammatory luminal Crohn's disease as demonstrated by superficial and/or deep ulcerations, pseudopolyps, and/or ulcerated stenosis on colonoscopy within 8 weeks of screening.
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- Patients who are receiving corticosteroids must be on a prednisone equivalent dose less than or equal to 25 mg/day or an oral (PO) budesonide dose less than or equal to 9 mg/day.
- Patients who are receiving any of the following concomitant Crohn's disease medications must have been on a stable dose of these medications for the specified period of time PRIOR TO confirmation of eligibility (this time period may include screening): aminosalicylates, antibiotics, and immunosuppressants (i.e., 6 MP, MTX, or AZA) for at least 4 weeks; corticosteroids or PO budesonide for at least 2 weeks; anti-TNF agents (i.e., infliximab or adalimumab) for at least 8 weeks.
- Patients who have failed treatment with immunosuppressants and/or anti-TNF agents.
- Patients who have fistulae are permitted, provided: patients have predominantly luminal Crohn's disease, and fistulae are not associated with abscess formation.
- Patients must have a platelet count greater than or equal to 50,000/microL (50.0 x 109/L).
- Female patients must be: postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control (acceptable methods include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening. Male patients must also commit to using adequate contraceptive precautions (condoms). All patients (both males and females of childbearing potential) must commit to using adequate contraceptive precautions throughout their participation in the study and for at least 3 months following their last ECP treatment
- Patients must be able and willing to comply with all study procedures.
Who cannot join
- Patients who are concomitantly using biologic agents other than anti-TNF agents; cyclosporine (CSA), tacrolimus (FK506), mycophenolate mofetil (MMF), or investigational Crohn's disease therapies.
- Patients who, in the opinion of the Investigator, may not be able to remain on a stable dose of a concomitant Crohn's disease medication during the 12-week Treatment Period.
- Patients with currently symptomatic untreated diarrhea, due to conditions other than inflammatory Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, or bacterial overgrowth).
- Patients with symptomatic intestinal strictures.
- Patients with stomas.
- Patients with other local manifestations of Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated, or which might preclude utilization of a CDAI to assess response to therapy (such as "short gut" syndrome).
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- Patients who are unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure.
- Patients receiving total parenteral nutrition, as the sole source of nutrition, within 3 weeks of screening.
- Female patients whose hemoglobin (Hgb) is < 8.5 g/dL or male patients whose Hgb is < 10.0 g/dL at screening.
- Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
- Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen).
- Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
- Female patients who are pregnant and/or lactating.
- Patients who have been enrolled in any investigational study for the treatment of Crohn's disease within 4 weeks of enrollment for non biologic therapies and within 8 weeks of enrollment for biologic therapies.
- Patients who have any of the following: a co-existing melanoma, squamous cell skin carcinoma, aphakia, photosensitive disease (e.g., porphyria, systemic lupus erythematosus, or albinism), a white blood cell count > 25,000 mm3, a previous splenectomy, or a clinically significant coagulation disorder.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany8 sites
Universitat St Josef
Bochum
Krankenhaus Duren gem.GmbH
Düren
Universitatsklinik Essen
Essen
Universitatsklinikum
Jena
Universitatsklinikum Mannheim
Mannheim
University Hospital Munich-Grosshadem
Munich
Klinikum Oldenberg
Oldenburg
Medizinische Universitatsklinik Ulm
Ulm
United States4 sites
NIH
Bethesda, Maryland
Metropolitian Gastroenterology Group
Chevy Chase, Maryland
Morristown Memorial Hospital
Morristown, New Jersey
Mount Sinai Medical Center
New York, New York
About this study
Official title: A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.
- Conditions
- Crohn's Disease
- Being tested
- Methoxsalen +ECP, Extracorporeal Photopheresis
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxsalen +ECPDrug
Also called Uvadex
ECP + Uvadex given at weeks 1-12 weeks.
Extracorporeal PhotopheresisProcedure or surgery
Also called uvadex+ECP
ECP given at weeks 1 through 12.
| Study group | Role | What they receive |
|---|---|---|
| drug | Experimental | ECP + Uvadex given for 12 weeks. Receives: Drug: Methoxsalen +ECP; Procedure: Extracorporeal Photopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohns Disease Activity Index
The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJun 2006
- Study completionJun 2006
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221026
- Sponsor's protocol ID
- CD-2
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2005
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents
- ClinicalTrials.gov ID
- NCT00221026
- Acronym / sponsor ID
- CD-2
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- Dec 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 22 Sep 2005 (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.
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug | Experimental | Drug: Methoxsalen +ECP, Procedure: Extracorporeal PhotopheresisECP + Uvadex given for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed and dated informed consent must be obtained prior to conducting any study procedure.
- Patients must be greater than or equal to 18 years of age.
- Patients must have a body weight greater than or equal to 40 kg (88 lb).
- Patients must have had Crohn's disease for at least 6 months duration (with colitis, ileitis, or ileocolitis) confirmed by radiography or endoscopy.
- Patients must have a CDAI greater than or equal to 220 to < 450.
Key exclusion criteria (15 listed)
- Patients who are concomitantly using biologic agents other than anti-TNF agents; cyclosporine (CSA), tacrolimus (FK506), mycophenolate mofetil (MMF), or investigational Crohn's disease therapies.
- Patients who, in the opinion of the Investigator, may not be able to remain on a stable dose of a concomitant Crohn's disease medication during the 12-week Treatment Period.
- Patients with currently symptomatic untreated diarrhea, due to conditions other than inflammatory Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, or bacterial overgrowth).
- Patients with symptomatic intestinal strictures.
- Patients with stomas.
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 |
|---|---|---|
| Methoxsalen +ECPAlso: UvadexECP + Uvadex given at weeks 1-12 weeks. | Drug | drug |
| Extracorporeal PhotopheresisAlso: uvadex+ECPECP given at weeks 1 through 12. | Procedure or surgery | drug |
Primary outcome
Crohns Disease Activity Index
Time frame: 12 weeks
The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.
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 19 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methoxsalen +ECP and Extracorporeal Photopheresis in people with Crohn's Disease, run by Mallinckrodt at 15 sites in 4 countries.
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 13 inclusion and 15 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, United States, Belgium, Austria. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Crohns Disease Activity Index (time frame: 12 weeks). 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 19 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.