Ankylosing SpondylitisPhase 4NCT00432432
Combination Methotrexate and Infliximab
A Phase 4 study testing Infliximab and MTX in people with Ankylosing Spondylitis, run by Chinese University of Hong Kong.
Trial summary
Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Infliximab and MTX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Oct 2006
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled the AS:meeting the modified New York criteria
- Active disease despite NSAID treatment defined as:
- Spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains
- Back pain
- Patient global assessment of disease activity
- Physical function
- Informed consent
Who cannot join
- Complete ankylosis of the spine
- On sulphasalazine
- Previous use of TNF inhibitors
- Multiple use of NSAIDS
- Prednisolone > 10mg/day
- Changes of NSAIDS or dose of prednisolone within 2 weeks of baseline
Show all 19Show fewer
- Little or no ability for self-care
- Received intra-articular,intramuscular, or intravenous corticosteroids in the 4 weeks before screening
- Infected joint prosthesis during the previous 5 years
- Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
- Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis
- Active tuberculosis requiring treatment within the previous 3 years
- Opportunistic infections such as herpes zoster within the previous 2 months
- Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection
- Known hypersensitivity to murine proteins
- Current signs or symptoms of severe,progressive,or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
- A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie,lymph nodes in the posterior triangle or the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly;
- Any known malignant disease except basal cell carcinoma currently or in the past 5 years.
- A hemoglobin level < 8.5 gm/dl, a white blood cell count < 3.5 × 10^9/liter, a platelet count < 100 × 10^9/liter, a serum creatinine level > 150 µmol/l, serum transaminase levels 1.25 times the upper limit of normal, or alkaline phosphatase levels > 2 times the upper limit of normal.
About this study
Official title: The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation
Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.
Read the detailed description
Forty consecutive patients will be recruited from the rheumatology clinic of the Prince of Wales Hospital with AS meeting the modified New York criteria with active disease as defined (see below). They will be randomized to receive MTX 7.5 mg/week initially with a weekly 2.5mg increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic acid 5mg daily for a period of 16 week. After 16 weeks, all patients will receive infliximab at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with MTX 15 mg/week or placebo. Thereafter, they will be followed up at week 30, 38 weeks. MRI changes in the sacroiliac joints (SI) before and after infliximab treatment.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Infliximab and MTX
- Keywords
- Ankylosing Spondylitis, MTX, Infliximab
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab and MTXDrug
Also called remicade
MTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | placebo with infliximab Receives: Drug: Infliximab and MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patient exhibited an ASAS 20 response to treatment at week 20.
Measured: wk52
Secondary outcomes (1)
Proportion of patients with 50% and 70% improvement in disease activity.Patient global assessment of disease activity and pain;BASFI;early morning stiffness;physician global assessment of disease activity.Changes in the pre and post infusion MRI.
Measured: wk52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startFeb 2005
- Primary completionAug 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 Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-Shan Tam, Chinese University of Hong Kong
- Investigators
- Edmund K Li, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432432
- Sponsor's protocol ID
- AS-2005-003
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2007
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation
- ClinicalTrials.gov ID
- NCT00432432
- Acronym / sponsor ID
- AS-2005-003
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, MTX, Infliximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 7 Feb 2007 (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.
Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.
Detailed description
Forty consecutive patients will be recruited from the rheumatology clinic of the Prince of Wales Hospital with AS meeting the modified New York criteria with active disease as defined (see below). They will be randomized to receive MTX 7.5 mg/week initially with a weekly 2.5mg increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic acid 5mg daily for a period of 16 week. After 16 weeks, all patients will receive infliximab at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with MTX 15 mg/week or placebo. Thereafter, they will be followed up at week 30, 38 weeks. MRI changes in the sacroiliac joints (SI) before and after infliximab treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Infliximab and MTXplacebo with infliximab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fulfilled the AS:meeting the modified New York criteria
- Active disease despite NSAID treatment defined as:
- Spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains
- Back pain
- Patient global assessment of disease activity
Key exclusion criteria (19 listed)
- Complete ankylosis of the spine
- On sulphasalazine
- Previous use of TNF inhibitors
- Multiple use of NSAIDS
- Prednisolone > 10mg/day
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 |
|---|---|---|
| Infliximab and MTXAlso: remicadeMTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6 | Drug | 2 |
Primary outcome
The number of patient exhibited an ASAS 20 response to treatment at week 20.
Time frame: wk52
1 secondary outcome
Proportion of patients with 50% and 70% improvement in disease activity.Patient global assessment of disease activity and pain;BASFI;early morning stiffness;physician global assessment of disease activity.Changes in the pre and post infusion MRI.
Time frame: wk52
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 13 Feb 2012.
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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.
Edmund K Li, MD principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and MTX in people with Ankylosing Spondylitis, run by Chinese University of Hong Kong.
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 19 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 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The number of patient exhibited an ASAS 20 response to treatment at week 20. (time frame: wk52). 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 13 Feb 2012.