Crohn's DiseaseT2NCT01015391
Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease
A study testing T2 and Azathioprine in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced remission. The side effects related to T2 and AZA will also be monitored throughout the study. 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?
- T2 and Azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Jun 2013
- Phase
- Interventional
- 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
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
- Lesions located in ileum or ileocecal region
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Body weight between 40 and 100 kg, inclusive.
- Subjects should have a CDAI score <150 at week 0
Show all 9Show fewer
- Able to swallow tablets
- Are capable of providing written informed consent and obtained at the time of enrollment
- Willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Bacterial,viral or other microbial infection(including HIV)
- any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
- any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab.
- current use of prescription doses or chronic/frequent use of NSAIDs
Show all 15Show fewer
- Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.)
- With an ileal or colonic stoma.
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
- WBC <3.0 x 109/L, hemoglobin <80 g/L, Platelets<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known)
- History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)
- With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)
- History of malignancy
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- Participation in other clinical trial within the past 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Institute,Jinling Hospital
Nanjing, Jiangsu, 210000
Weiming Zhu, PhD,MD, +86-25-80860137, juwiming@yahoo.com.cn
Weiming Zhu, PhD,MD
About this study
Official title: A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection
The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced remission.
The side effects related to T2 and AZA will also be monitored throughout the study.
Read the detailed description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment. Surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of patients and is a serious limitation of surgical management. Patients' quality of life is often severely diminished. Currently available therapeutic options for the maintenance of remission in Crohn's disease are inadequate. A clear need exists for well-tolerated drugs that can reliably reduce the risk of a disease relapse.
AZA is classical immunomodulator,often applied to hematologic diseases and immune-related diseases,also the most commonly used drug in the maintenance of remission in Crohn's disease, it is indicated in steroid resistant or dependent patients, in those whose frequency of relapse is >1 per year, in patients after induction of remission with IFX, and in patients whose remission were induced by surgical resection. However, AZA may cause some adverse effects,the most serious adverse effect is leucopenia, which can develop suddenly and unpredictably, though it is rare (around 3%).
T2 is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.
- Conditions
- Crohn's Disease
- Being tested
- T2, Azathioprine
- Keywords
- T2, AZA, remission, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2Drug
1.5mg/kg/day, PO (per oral),three times a day: until progression or unacceptable toxicity develops
AzathioprineDrug
2.5mg/kg, PO (per oral) one time a day:until progression or unacceptable toxicity develops the first month:1.5mg/kg,PO,one time a day the second month:2.0mg/kg,PO,one time a day since the third month:2.5mg/kg,PO,one time a day
| Study group | Role | What they receive |
|---|---|---|
| T2 | Experimental | Not described Receives: Drug: T2 |
| AZA | Active comparator | Not described Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission: the proportion of patients with CDAI <150 at 26 and 52 weeks
Measured: 52 weeks
Endoscopic Remission: the proportion of patients with CDEIS <6 at 26 and 52 weeks
Measured: 52 weeks
Secondary outcomes (4)
The time till the clinical relapse of CD(the CDAI >150 or an increase of more than 70 points)
Measured: 52 weeks
The time till the histological recurrence(determined by biopsies and endoscopic findings)
Measured: 52 weeks
Serum C-reactive protein concentration; Erythrocyte Sedimentation Rate
Measured: 52 weeks
The proportion of patients experiencing adverse events
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
- Investigators
- Weiming Zhu, PhD,MD, Principal investigator, General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015391
- Sponsor's protocol ID
- TW2-001
- Acronym
- T2
- Status last verified
- Jun 2013
- First submitted
- 17 Nov 2009
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanauer SB, Korelitz BI, Rutgeerts P, Peppercorn MA, Thisted RA, Cohen RD, Present DH. Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial. Gastroenterology. 2004 Sep;127(3):723-9. doi: 10.1053/j.gastro.2004.06.002.
PubMed 15362027Almer SH, Hjortswang H, Hindorf U. 6-Thioguanine therapy in Crohn's disease--observational data in Swedish patients. Dig Liver Dis. 2009 Mar;41(3):194-200. doi: 10.1016/j.dld.2008.07.314. Epub 2008 Sep 16.
PubMed 18799369Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G, Costello R, Pham TH, Snyder C, van der Heijde D, Tao X, Wesley R, Lipsky PE. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51. doi: 10.7326/0003-4819-151-4-200908180-00005.
PubMed 19687490Peyrin-Biroulet L, Deltenre P, Ardizzone S, D'Haens G, Hanauer SB, Herfarth H, Lemann M, Colombel JF. Azathioprine and 6-mercaptopurine for the prevention of postoperative recurrence in Crohn's disease: a meta-analysis. Am J Gastroenterol. 2009 Aug;104(8):2089-96. doi: 10.1038/ajg.2009.301. Epub 2009 Jun 30.
PubMed 19568226Ren J, Tao Q, Wang X, Wang Z, Li J. Efficacy of T2 in active Crohn's disease: a prospective study report. Dig Dis Sci. 2007 Aug;52(8):1790-7. doi: 10.1007/s10620-007-9747-y. Epub 2007 Apr 5.
PubMed 17410440Wei X, Gong J, Zhu J, Niu L, Zhu W, Li N, Li J. Therapeutic effects of triptolide on interleukin-10 gene-deficient mice with colitis. Int Immunopharmacol. 2008 Dec 20;8(13-14):1808-12. doi: 10.1016/j.intimp.2008.08.019. Epub 2008 Sep 17.
PubMed 18804190Wei X, Gong J, Zhu J, Wang P, Li N, Zhu W, Li J. The suppressive effect of triptolide on chronic colitis and TNF-alpha/TNFR2 signal pathway in interleukin-10 deficient mice. Clin Immunol. 2008 Nov;129(2):211-8. doi: 10.1016/j.clim.2008.07.018. Epub 2008 Aug 30.
PubMed 18757245Caprilli R, Gassull MA, Escher JC, Moser G, Munkholm P, Forbes A, Hommes DW, Lochs H, Angelucci E, Cocco A, Vucelic B, Hildebrand H, Kolacek S, Riis L, Lukas M, de Franchis R, Hamilton M, Jantschek G, Michetti P, O'Morain C, Anwar MM, Freitas JL, Mouzas IA, Baert F, Mitchell R, Hawkey CJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: special situations. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i36-58. doi: 10.1136/gut.2005.081950c.
PubMed 16481630Travis SP, Stange EF, Lemann M, Oresland T, Chowers Y, Forbes A, D'Haens G, Kitis G, Cortot A, Prantera C, Marteau P, Colombel JF, Gionchetti P, Bouhnik Y, Tiret E, Kroesen J, Starlinger M, Mortensen NJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i16-35. doi: 10.1136/gut.2005.081950b.
PubMed 16481629Stange EF, Travis SP, Vermeire S, Beglinger C, Kupcinkas L, Geboes K, Barakauskiene A, Villanacci V, Von Herbay A, Warren BF, Gasche C, Tilg H, Schreiber SW, Scholmerich J, Reinisch W; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i1-15. doi: 10.1136/gut.2005.081950a. No abstract available.
PubMed 16481628
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection
- ClinicalTrials.gov ID
- NCT01015391
- Acronym / sponsor ID
- T2 / TW2-001
- Conditions
- Crohn's Disease
- Keywords
- T2, AZA, remission, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 18 Nov 2009 (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 see whether T2 versus Azathioprine is able to maintain the clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced remission.
The side effects related to T2 and AZA will also be monitored throughout the study.
Detailed description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment. Surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of patients and is a serious limitation of surgical management. Patients' quality of life is often severely diminished. Currently available therapeutic options for the maintenance of remission in Crohn's disease are inadequate. A clear need exists for well-tolerated drugs that can reliably reduce the risk of a disease relapse.
AZA is classical immunomodulator,often applied to hematologic diseases and immune-related diseases,also the most commonly used drug in the maintenance of remission in Crohn's disease, it is indicated in steroid resistant or dependent patients, in those whose frequency of relapse is >1 per year, in patients after induction of remission with IFX, and in patients whose remission were induced by surgical resection. However, AZA may cause some adverse effects,the most serious adverse effect is leucopenia, which can develop suddenly and unpredictably, though it is rare (around 3%).
T2 is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2 | Experimental | Drug: T2 |
| AZA | Active comparator | Drug: Azathioprine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
- Lesions located in ileum or ileocecal region
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Body weight between 40 and 100 kg, inclusive.
Key exclusion criteria (15 listed)
- Bacterial,viral or other microbial infection(including HIV)
- any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
- any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab.
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 |
|---|---|---|
| T21.5mg/kg/day, PO (per oral),three times a day: until progression or unacceptable toxicity develops | Drug | T2 |
| Azathioprine2.5mg/kg, PO (per oral) one time a day:until progression or unacceptable toxicity develops the first month:1.5mg/kg,PO,one time a day the second month:2.0mg/kg,PO,one time a day since the third month:2.5mg/kg,PO,one time a day | Drug | AZA |
Primary outcome
Clinical Remission: the proportion of patients with CDAI <150 at 26 and 52 weeks
Time frame: 52 weeks
Endoscopic Remission: the proportion of patients with CDEIS <6 at 26 and 52 weeks
Time frame: 52 weeks
4 secondary outcomes
The time till the clinical relapse of CD(the CDAI >150 or an increase of more than 70 points)
Time frame: 52 weeks
The time till the histological recurrence(determined by biopsies and endoscopic findings)
Time frame: 52 weeks
Serum C-reactive protein concentration; Erythrocyte Sedimentation Rate
Time frame: 52 weeks
The proportion of patients experiencing adverse events
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Background: PubMed 15362027Hanauer SB, Korelitz BI, Rutgeerts P, Peppercorn MA, Thisted RA, Cohen RD, Present DH. Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial. Gastroenterology. 2004 Sep;127(3):723-9. doi: 10.1053/j.gastro.2004.06.002.
- Background: PubMed 18799369Almer SH, Hjortswang H, Hindorf U. 6-Thioguanine therapy in Crohn's disease--observational data in Swedish patients. Dig Liver Dis. 2009 Mar;41(3):194-200. doi: 10.1016/j.dld.2008.07.314. Epub 2008 Sep 16.
- Background: PubMed 19687490Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G, Costello R, Pham TH, Snyder C, van der Heijde D, Tao X, Wesley R, Lipsky PE. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51. doi: 10.7326/0003-4819-151-4-200908180-00005.
- Background: PubMed 19568226Peyrin-Biroulet L, Deltenre P, Ardizzone S, D'Haens G, Hanauer SB, Herfarth H, Lemann M, Colombel JF. Azathioprine and 6-mercaptopurine for the prevention of postoperative recurrence in Crohn's disease: a meta-analysis. Am J Gastroenterol. 2009 Aug;104(8):2089-96. doi: 10.1038/ajg.2009.301. Epub 2009 Jun 30.
- Background: PubMed 17410440Ren J, Tao Q, Wang X, Wang Z, Li J. Efficacy of T2 in active Crohn's disease: a prospective study report. Dig Dis Sci. 2007 Aug;52(8):1790-7. doi: 10.1007/s10620-007-9747-y. Epub 2007 Apr 5.
- Background: PubMed 18804190Wei X, Gong J, Zhu J, Niu L, Zhu W, Li N, Li J. Therapeutic effects of triptolide on interleukin-10 gene-deficient mice with colitis. Int Immunopharmacol. 2008 Dec 20;8(13-14):1808-12. doi: 10.1016/j.intimp.2008.08.019. Epub 2008 Sep 17.
- Background: PubMed 18757245Wei X, Gong J, Zhu J, Wang P, Li N, Zhu W, Li J. The suppressive effect of triptolide on chronic colitis and TNF-alpha/TNFR2 signal pathway in interleukin-10 deficient mice. Clin Immunol. 2008 Nov;129(2):211-8. doi: 10.1016/j.clim.2008.07.018. Epub 2008 Aug 30.
- Background: PubMed 16481630Caprilli R, Gassull MA, Escher JC, Moser G, Munkholm P, Forbes A, Hommes DW, Lochs H, Angelucci E, Cocco A, Vucelic B, Hildebrand H, Kolacek S, Riis L, Lukas M, de Franchis R, Hamilton M, Jantschek G, Michetti P, O'Morain C, Anwar MM, Freitas JL, Mouzas IA, Baert F, Mitchell R, Hawkey CJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: special situations. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i36-58. doi: 10.1136/gut.2005.081950c.
- Background: PubMed 16481629Travis SP, Stange EF, Lemann M, Oresland T, Chowers Y, Forbes A, D'Haens G, Kitis G, Cortot A, Prantera C, Marteau P, Colombel JF, Gionchetti P, Bouhnik Y, Tiret E, Kroesen J, Starlinger M, Mortensen NJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i16-35. doi: 10.1136/gut.2005.081950b.
- Background: PubMed 16481628Stange EF, Travis SP, Vermeire S, Beglinger C, Kupcinkas L, Geboes K, Barakauskiene A, Villanacci V, Von Herbay A, Warren BF, Gasche C, Tilg H, Schreiber SW, Scholmerich J, Reinisch W; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i1-15. doi: 10.1136/gut.2005.081950a. No abstract available.
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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.
Weiming Zhu, PhD,MD principal investigator
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2 and Azathioprine in people with Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiming Zhu, PhD,MD (+86-25-80860137, juwiming@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission: the proportion of patients with CDAI <150 at 26 and 52 weeks (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015391, which also lists 10 linked publications.
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 Jun 2013.