SpondylitisPhase 4NCT00936143
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
A Phase 4 study testing infliximab in people with Spondylitis, run by Gu Jieruo at 1 site in China.
Trial summary
This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spondylitis
- What is being tested?
- infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 4
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 to 65 years old, having signed the informed consent;
- fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- have inflammatory back pain defined by Calin criteria;
- disease duration range from 6 months to 2 years;
- BASDAI score more than 4;
- MRI score of sacroiliac joint more than 4;
- lab examination: hemoglobin more than 90 gram/liter. Aspartate aminotransferase and Alanine aminotransferase less than 2 fold of upper level of normal range. Creatine less than upper level of normal range.
Who cannot join
- History of psoriasis or inflammatory bowel disease.
- Intra-articular injection of cortisone within 3 months.
- Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
- Active iritis.
- History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
- Female of pregnancy or breast feeding.
- History of mental disease and poor compliance.
- History of drug abuse or alcoholism.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.
- Conditions
- Spondylitis
- Being tested
- infliximab
- Keywords
- Spondylitis, Ankylosing, infliximab, Antibodies, Monoclonal
- Medical subject headings
- Spondylitis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabDrug
Also called remicade
100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
| Study group | Role | What they receive |
|---|---|---|
| infliximab | Experimental | 200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week Receives: Drug: infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving ASAS20 improvement.
Measured: 6th week
Secondary outcomes (1)
Proportion of patients achieving ASAS50 and ASAS70
Measured: 6th week and 24 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gu Jieruo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gu Jieruo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936143
- Sponsor's protocol ID
- REM-CHN-IIS-01
- Status last verified
- Jan 2016
- First submitted
- 7 Jul 2009
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00936143
- Acronym / sponsor ID
- REM-CHN-IIS-01
- Conditions
- Spondylitis
- Keywords
- Spondylitis, Ankylosing, infliximab, Antibodies, Monoclonal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gu JieruoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Jul 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.
This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infliximab | Experimental | Drug: infliximab200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 16 to 65 years old, having signed the informed consent;
- fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- have inflammatory back pain defined by Calin criteria;
- disease duration range from 6 months to 2 years;
- BASDAI score more than 4;
Key exclusion criteria (8 listed)
- History of psoriasis or inflammatory bowel disease.
- Intra-articular injection of cortisone within 3 months.
- Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
- Active iritis.
- History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
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 |
|---|---|---|
| infliximabAlso: remicade100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week | Drug | infliximab |
Primary outcome
Proportion of patients achieving ASAS20 improvement.
Time frame: 6th week
1 secondary outcome
Proportion of patients achieving ASAS50 and ASAS70
Time frame: 6th week and 24 week.
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 26 Jan 2016.
Related trials for Spondylitis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
RecruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infliximab in people with Spondylitis, run by Gu Jieruo 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 7 inclusion and 8 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 26 Jan 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients achieving ASAS20 improvement. (time frame: 6th week). 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 26 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.