Crohn DiseasePhase 3NCT00206674
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 70 sites in 9 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
- 286 participants
- Where
- 70 sitesin 9 countries
- Study dates
- Sep 2004to Jun 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
- Stable but active Crohn's disease at the time of screening
- Must be able to self-inject or have another person who can help with the injection
Who cannot join
- Not have a colostomy or ileostomy
- Not be taking prohibited medications as defined in the protocol
- Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
- Not have ever taken this drug or drugs of similar type in the past
Trial locations and contacts
70 sites in 9 countries.
70 sites in 9 countries
Australia17 sites
Study site
Adelaide, South Australia, 5043
Study site
Ballarat, Victoria, 3350
Study site
Brisbane, Queensland, 4029
Study site
Brisbane, Queensland, 4101
Study site
Concord, New South Wales, 2139
Study site
Frankston, Victoria, 3199
Study site
Fremantle, Western Australia, 6160
Study site
Garran, Australian Capital Territory, 2605
Study site
Launceston, Tasmania, 7250
Study site
Melbourne, Victoria, 3065
Study site
Melbourne, Victoria, 3128
Study site
New Lambton Heights, New South Wales, 2305
Study site
Parkville, Victoria, 3050
Study site
Penrith, 2751
Study site
Prahran, Victoria, 3181
Study site
Sydney, New South Wales, 2050
Study site
Sydney, New South Wales, 2200
Canada17 sites
Study site
Edmonton, Alberta, T5H 4B9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Kelowna, British Columbia, V1Y 2H4
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H3A 1A1
Study site
Montreal, Quebec, H3G 1A4
Study site
Montreal, Quebec, H3T 1E2
Study site
Québec, Quebec, G1S 4L8
Study site
Sherbrooke, Quebec, J1G 2E9
Study site
Toronto, Ontario, M3N 2V7
Study site
Toronto, Ontario, M5G 1X5
Study site
Vancouver, British Columbia, V5Z 1H2
Study site
Vancouver, British Columbia, V6Z 2K5
Study site
Victoria, British Columbia, V8R 6T9
Study site
Windsor, Ontario, N9A 1L9
Study site
Winnipeg, Manitoba, R3A 1R9
United Kingdom10 sites
Study site
Bristol, Avon, BS2 8HW
Study site
Cardiff, South Glamorgan, CF14 4XW
Study site
Edinburgh, Lothian, EH4 2XU
Study site
Harrow, Middlesex, HA1 3UJ
Study site
Liverpool, Merseyside, L7 8XP
Study site
London, Greater London, W12 0HS
Study site
London, WC1E 6AU
Study site
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Study site
Salford, Greater Manchester, M6 8HD
Study site
Sheffield, S10 2JF
Russia7 sites
Study site
Lipetsk, Russia, 398055
Study site
Moscow, 123154
Study site
Moscow, 129110
Study site
Moskva, Russia, 105203
Study site
Moskva, 127015
Study site
Samara, Russia, 443023
Study site
Volgograd, 400107
Brazil6 sites
Study site
Curitiba, Paraná, 80060-900
Study site
Porto Alegre, Rio Grande do Sul
Study site
Rio de Janeiro, Rio de Janeiro, 21949 900
Study site
Salvador, Estado de Bahia, 40110060
Study site
São Paulo, São Paulo, 05403-900
Study site
São Paulo, São Paulo, 05651-901
Ukraine5 sites
Study site
Donetsk, 83017
Study site
Kharkiv, 61001
Study site
Kiev, 03049
Study site
Lviv, 49044
Study site
Vinnitsa, 26014
New Zealand3 sites
Study site
Christchurch, 8011
Study site
Hamilton, 3204
Study site
Milford, Auckland, 1309
Switzerland3 sites
Study site
Basel, Basel, 4031
Study site
Bern, Canton of Bern, 3010
Study site
Lausanne, Canton of Vaud, 1011
Argentina2 sites
Study site
Buenos Aires, Buenos Aires F.D., C1118AAT
Study site
Buenos Aires, Buenos Aires F.D., C1264AAA
About this study
Official title: Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) 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
- Keywords
- Morbus Crohn, Sargramostim, Phase III, Placebo Controlled
- 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
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
PlaceboDrug
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
| 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.
Induction of clinical response and/or remission as defined by decrease in CDAI score
Measured: After 8 weeks of treatment
Secondary outcomes (3)
Time and duration to response/remission
Measured: During the 8 weeks of treatment
QoL (different methods)
Measured: During the whole study
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
Measured: About 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 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 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
- Double blind
- Enrolment
- 286 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
- NCT00206674
- Sponsor's protocol ID
- 308380
- Other IDs
- 91405, Novel 4
- Status last verified
- Dec 2013
- First submitted
- 13 Sep 2005
- 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
- Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00206674
- Acronym / sponsor ID
- 308380
- Conditions
- Crohn Disease
- Keywords
- Morbus Crohn, Sargramostim, Phase III, Placebo Controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 21 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.
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
- Double blind
- 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 (2 listed)
- Stable but active Crohn's disease at the time of screening
- Must be able to self-inject or have another person who can help with the injection
Key exclusion criteria (4 listed)
- Not have a colostomy or ileostomy
- Not be taking prohibited medications as defined in the protocol
- Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
- Not have ever taken this drug or drugs of similar type in the past
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: BAY86-53266µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks | Drug | Arm 1 |
| PlaceboSterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks | Drug | Arm 2 |
Primary outcome
Induction of clinical response and/or remission as defined by decrease in CDAI score
Time frame: After 8 weeks of treatment
3 secondary outcomes
Time and duration to response/remission
Time frame: During the 8 weeks of treatment
QoL (different methods)
Time frame: During the whole study
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
Time frame: About 20 months
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 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
70 sites in 9 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 70 sites in 9 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 2 inclusion and 4 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 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 70 sites in Australia, Canada, United Kingdom, Russia, Brazil and 4 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 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?
Induction of clinical response and/or remission as defined by decrease in CDAI score (time frame: After 8 weeks of treatment). 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.