Crohn DiseasePhase 3NCT00295165
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
A Phase 3 study testing Sargramostim (Leukine) in people with Crohn Disease, run by Genzyme, a Sanofi Company at 111 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Sargramostim (Leukine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 111 sitesin 11 countries
- Study dates
- Jan 2006to Oct 2006
- Phase
- Phase 3
- 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
- Written informed consent
- Male or female, age >/= 18 years
- Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
- Moderately to severely active Crohn's disease at time of screening (i.e., CDAI greater than or equal to 220 and less than or equal to 475 points)
- If under treatment for Crohn's disease, medication must be stable for at least 4 weeks prior to receiving the first dose of study drug. The following therapies are allowed:
- Oral therapy with salicylates (mesalamine, sulfasalazine, olsalazine, or balsalazide) for Crohn's disease
Show all 13Show fewer
- Antibiotics or probiotics for Crohn's disease
- Topical rectal therapy with mesalamine
- Females of child-bearing potential:
- Negative pregnancy test within 72 hours prior to receiving the first dose of study drug
- Sexually-active males and females of child-bearing potential:
- Agreement to use adequate method of contraception throughout the study
- Ability to self-inject study drug or availability of a designee who can do so
Who cannot join
- Pregnancy or breast-feeding
- Colostomy or ileostomy
- Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
- GI surgery within 6 months prior to receiving the first dose of study drug
- Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
- Positive stool test results for any of the following:
Show all 45Show fewer
- Bacteria:
- Salmonella spec.
- Shigella spec.
- Campylobacter spec.
- Bacterial toxin:
- Clostridium difficile
- Ova and parasites:
- Amoeba spec.
- Giardia spec.
- Cryptosporidium spec.
- Any of the following laboratory abnormalities:
- Serum creatinine >/= 2.0 mg/dL
- Alkaline phosphatase (AP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >/=; 2 x the upper limit of normal
- Hemoglobin (Hgb) < 8.0 g/dL
- Absolute neutrophil count (ANC) </= 1,000 cells/µL or > cells 20,000/µL
- Planned in-patient hospitalization during the study
- Presence or history of cancer of any type (except treated basal cell carcinoma) or definite dysplasia of the colon within the last 5 years
- Use of any of the following medications during the specified period of time prior to receiving the first dose of study drug:
- At any time:
- Recombinant human GM CSF (sargramostim or molgramostim)
- Granulocyte colony-stimulating factor (G CSF; filgrastim or pegfilgrastim)
- Natalizumab 8 weeks: or 5 half-lives (whichever is longer)
- Licensed/registered and/or experimental anti-tumor necrosis factor (TNF) therapy such as infliximab or adalimumab 4 weeks:
- 6-mercaptopurine
- Azathioprine
- Cyclophosphamide
- Methotrexate
- Mycophenolate mofetil
- Tacrolimus
- Cyclosporine
- Thalidomide
- Glucocorticoids, including budesonide and prednisone, or local glucocorticoid therapy for Crohn's disease
- Any other immunosuppressive drugs
- Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug
- Use of nutritional therapy (parenteral nutrition or enteral nutrition with elemental or semi-elemental diets) within 4 weeks prior to receiving the first dose of study drug. If the physician judges that nutritional supplementation is needed, enteral nutritional supplements will be allowed for patients who have been receiving a stable regimen for at least 4 weeks prior to receiving the first dose of study drug and that is intended to continue through the 8 week treatment period.
- History of allergy to yeast products or to sargramostim or to any other excipient of the study drug formulation
- Active drug or alcohol abuse
- Clinically important co-morbid conditions unrelated to Crohn's disease as determined by the investigator
- Previous randomization into this study, or into any other study of the sponsor's sargramostim development program
Trial locations and contacts
111 sites in 11 countries.
111 sites in 11 countries
United States47 sites
Study site
Ann Arbor, Michigan, 48109-0330
Study site
Atlanta, Georgia, 30342
Study site
Boca Raton, Florida, 33486
Study site
Charlotte, North Carolina, 28207
Study site
Charlottesville, Virginia, 22908
Study site
Chesapeake, Virginia, 23320
Study site
Chesterfield, Michigan, 48047
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Christiansburg, Virginia, 24073
Study site
Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45242
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Cleveland, Ohio, 44195
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Columbia, South Carolina, 29203
Study site
Dayton, Ohio, 45440
Study site
Florham Park, New Jersey, 07932
Study site
Gainesville, Florida, 32610-0254
Study site
Great Neck, New York, 11021
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Hagerstown, Maryland, 21740
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46202
Study site
Lakewood, Colorado, 80215
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Lexington, Kentucky, 40536
Study site
Lincoln, Nebraska, 68503
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Littleton, Colorado, 80120
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Louisville, Kentucky, 40202
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Lutherville, Maryland, 21093
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Mexico, Missouri, 65265
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Mineola, New York, 11501-3987
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New Brunswick, New Jersey, 08901
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New York, New York, 10028
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Norfolk, Virginia, 23502
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Oklahoma City, Oklahoma, 73104
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Orange, California, 92868
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Plymouth, Minnesota, 55446
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Raleigh, North Carolina, 27612
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Richmond, Virginia, 23249-0002
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San Antonio, Texas, 78229
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San Francisco, California, 94117
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Sayre, Pennsylvania, 18840
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Seattle, Washington, 98195
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St Louis, Missouri, 63110
Study site
Syracuse, New York, 13210
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Towson, Maryland, 21204
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Troy, Michigan, 48098
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Tulsa, Oklahoma, 74104
Study site
Washington D.C., District of Columbia, 20007-2197
Study site
Wenatchee, Washington, 98801
Study site
Winston-Salem, North Carolina, 27157
South Africa11 sites
Study site
Cape Town, Western Cape, 7463
Study site
Cape Town, Western Cape, 7530
Study site
Cape Town, Western Cape, 7708
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Cape Town, Western Cape
Study site
Durban, 4001
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Durban
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Johannesburg, Gauteng, 2193
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Johannesburg, Gauteng
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Port Elizabeth, Eastern Cape, 6057
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Pretoria, Gauteng
Study site
Somerset West, Western Cape, 7130
Canada10 sites
Study site
Abbotsford British Columbia, British Columbia, V2S 3N5
Study site
Guelph, Ontario, N1H 3R3
Study site
Kingston, Ontario, K7L 5G2
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Montreal, Quebec, H3H 1V4
Study site
Ottawa, Ontario, K1H 8L6
Study site
Québec, Quebec, G1R 2J6
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Saint John, New Brunswick, E2K 1J5
Study site
Saint-Charles-Borromée, Quebec, J6E 2C3
Study site
St. John's, Newfoundland and Labrador, A1B 3V6
Study site
Winnipeg, Manitoba, R3C 0N2
Australia8 sites
Study site
Adelaide, South Australia, 5000
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Brisbane, QLD 4000
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Caboolture, Queensland
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Frankston, Victoria, 3199
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Hamilton, 3204
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Liverpool, New South Wales, 2170
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Melbourne, Victoria, 3084
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Sydney
Russia7 sites
Study site
Kazan', 420011
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Krasnodar, 350086
Study site
Moskva, 119992
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Saint Petersburg, 194017
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 197110
Study site
Saint Petersburg
Brazil6 sites
Study site
Blumenau, Santa Catarina, 89010-205
Study site
Botucatu, São Paulo, 18618-970
Study site
Florianópolis, Santa Catarina, 88020-210
Study site
Santos, 11075-900
Study site
São Paulo, São Paulo, 0122-1020
Study site
São Paulo, São Paulo, 04023-900
Ukraine6 sites
Study site
Dnipro
Study site
Ivano-Frankivsk
Study site
Kharkiv, 61039
Study site
Kiev
Study site
Lviv, 79013
Study site
Zaporizhzhya
Israel5 sites
Study site
Haifa, Israel, 31048
Study site
Jerusalem, 91120
Study site
Rehovot, 76100
Study site
Tel Aviv, 64299
Study site
Tsrifin, Israel, 70300
Bulgaria4 sites
Study site
Sofia, 1233
Study site
Sofia, 1431
Study site
Sofia, 1527
Study site
Varna, 9010
New Zealand4 sites
Study site
Auckland, 0622
Study site
Dunedin, 9016
Study site
Hamilton, 3204
Study site
Tauranga
Romania3 sites
Study site
Bucharest, 011025
Study site
Bucharest
Study site
Craiova, 200670
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
Read the detailed description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
- Conditions
- Crohn Disease
- Being tested
- Sargramostim (Leukine), Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sargramostim (Leukine)Drug
Also called BAY86-5326
Sargramostim 6 mcg/kg subcutaneously once daily
PlaceboDrug
Placebo subcutaneously once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sargramostim (Leukine) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To induce clinical remission and/or clinical response following 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (2)
To assess the safety profile of sargramostim (including development of antibodies against sargramostim)
Measured: During study treatment
To assess quality of life (QoL)
Measured: During study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295165
- Sponsor's protocol ID
- 310187
- Other IDs
- 91494, NOVEL8
- Status last verified
- Dec 2013
- First submitted
- 21 Feb 2006
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00295165
- Acronym / sponsor ID
- 310187
- Conditions
- Crohn Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 23 Feb 2006 (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.
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
Detailed description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sargramostim (Leukine) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent
- Male or female, age >/= 18 years
- Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
- Moderately to severely active Crohn's disease at time of screening (i.e., CDAI greater than or equal to 220 and less than or equal to 475 points)
- If under treatment for Crohn's disease, medication must be stable for at least 4 weeks prior to receiving the first dose of study drug. The following therapies are allowed:
Key exclusion criteria (45 listed)
- Pregnancy or breast-feeding
- Colostomy or ileostomy
- Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
- GI surgery within 6 months prior to receiving the first dose of study drug
- Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
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 |
|---|---|---|
| Sargramostim (Leukine)Also: BAY86-5326Sargramostim 6 mcg/kg subcutaneously once daily | Drug | Arm 1 |
| PlaceboPlacebo subcutaneously once daily | Drug | Arm 2 |
Primary outcome
To induce clinical remission and/or clinical response following 8 weeks of treatment
Time frame: 8 weeks
2 secondary outcomes
To assess the safety profile of sargramostim (including development of antibodies against sargramostim)
Time frame: During study treatment
To assess quality of life (QoL)
Time frame: During study treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
111 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sargramostim (Leukine) in people with Crohn Disease, run by Genzyme, a Sanofi Company at 111 sites in 11 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 45 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: stopped early, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, South Africa, Canada, Australia, Russia and 6 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
To induce clinical remission and/or clinical response following 8 weeks of treatment (time frame: 8 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 4 Dec 2013.