Ankylosing SpondylitisNCT01361542
Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population
A study testing anti TNF alpha agent and Anti TNF alpha therapy in people with Ankylosing Spondylitis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of unknown etiology primarily affecting the spine and sacroiliac joints. In addition to formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a prominent feature in AS-thus showing the paradox of new bone… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- anti TNF alpha agent and Anti TNF alpha therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Jan 2012
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are fulfilling the Modified New York Criteria(1984) for the diagnosis of Ankylosing Spondylitis
- Age ≥ 18 years
- Patients who have been planned to be started on anti Tnf alpha agents.
- Patients who have given consent for the study.
Who cannot join
- Patients with other coexistent rheumatologic diseases.
- Patients who have previously received anti TNF alpha agents in the past 1 year.
- Patients who are receiving other medications that may significantly alter the bone metabolism (like steroids, bisphosphonates, estrogen replacement therapy etc)
- Patients with any contraindications against the usage of anti TNF alpha agents (Active/ chronic infections, liver dysfunction, demyelinating diseases, pregnancy etc)
- Patients with other definite risk factors for osteoporosis like chronic alcoholism, smoking, endocrine disorders etc
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Effect Of Anti TNF Alpha Therapy On Disease Activity And Bone Health, And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population
Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of unknown etiology primarily affecting the spine and sacroiliac joints. In addition to formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites coexisting with reduced bone mass \& increased fracture risk. Osteoporosis is a common complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is effective in active AS resistant to conventional therapy and helps in improving the bone density and over all bone health.
Read the detailed description
Ankylosing spondylitis not responding to conventional therapy has been effectively treated with Anti TNF therapy. In addition studies have shown that TNF has a role in osteoporosis of inflammatory diseases. The hypothesis that anti TNF therapy may decrease osteoporosis and tilt bone metabolism to the osteoblastic side has been tested in few studies. These have not been studied in an Indian population. Another great issue in the usage of anti TNF therapy in Indian population is the high incidence of developing infective complications; especially tuberculosis. The investigators are thus studying these in a north Indian population at a tertiary centre. The results would come to important conclusions regarding treatment and in the important issue of tuberculosis screening and prevention.
- Conditions
- Ankylosing Spondylitis
- Being tested
- anti TNF alpha agent, Anti TNF alpha therapy
- Keywords
- TNF, BMD, Ankylosing spondylitis, bone health, Anti TNF therapy, Disease activity
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti TNF alpha agentDrug
Also called Infliximab - REMICADE as brand name, Etanercept- ENBREL as brand name
Anti TNF alpha therapy included either INFLIXIMAB or ETANERCEPY Infliximab at 3-5 mg/kg at recommended protocols for the duration of the study Etanercept at 50mg weekly for the duration of the study
Anti TNF alpha therapyDrug
Also called REMICADE-infliximab, ENBREL-Etanercept
Infliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Anti TNF | Experimental | Anti TNF alpha therapy including either infliximab or etanercept with data obtained before and after the study duration. Receives: Drug: anti TNF alpha agent; Drug: Anti TNF alpha therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in bone mineral density and decrease in disease activity
Measured: 2 years
Secondary outcomes (1)
Observation of adverse effects of Anti TNF therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.K.SHARMA, All India Institute of Medical Sciences
- Investigators
- Surendra K Sharma, MD, PhD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361542
- Sponsor's protocol ID
- SKS/ASTNF/TB/2011
- Status last verified
- Jan 2012
- First submitted
- 24 May 2011
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Franck H, Meurer T, Hofbauer LC. Evaluation of bone mineral density, hormones, biochemical markers of bone metabolism, and osteoprotegerin serum levels in patients with ankylosing spondylitis. J Rheumatol. 2004 Nov;31(11):2236-41.
PubMed 15517638
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Anti TNF Alpha Therapy On Disease Activity And Bone Health, And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population
- ClinicalTrials.gov ID
- NCT01361542
- Acronym / sponsor ID
- SKS/ASTNF/TB/2011
- Conditions
- Ankylosing Spondylitis
- Keywords
- TNF, BMD, Ankylosing spondylitis, bone health, Anti TNF therapy, Disease activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 May 2011 (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.
Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of unknown etiology primarily affecting the spine and sacroiliac joints. In addition to formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites coexisting with reduced bone mass \& increased fracture risk. Osteoporosis is a common complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is effective in active AS resistant to conventional therapy and helps in improving the bone density and over all bone health.
Detailed description
Ankylosing spondylitis not responding to conventional therapy has been effectively treated with Anti TNF therapy. In addition studies have shown that TNF has a role in osteoporosis of inflammatory diseases. The hypothesis that anti TNF therapy may decrease osteoporosis and tilt bone metabolism to the osteoblastic side has been tested in few studies. These have not been studied in an Indian population. Another great issue in the usage of anti TNF therapy in Indian population is the high incidence of developing infective complications; especially tuberculosis. The investigators are thus studying these in a north Indian population at a tertiary centre. The results would come to important conclusions regarding treatment and in the important issue of tuberculosis screening and prevention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti TNF | Experimental | Drug: anti TNF alpha agent, Drug: Anti TNF alpha therapyAnti TNF alpha therapy including either infliximab or etanercept with data obtained before and after the study duration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are fulfilling the Modified New York Criteria(1984) for the diagnosis of Ankylosing Spondylitis
- Age ≥ 18 years
- Patients who have been planned to be started on anti Tnf alpha agents.
- Patients who have given consent for the study.
Key exclusion criteria (5 listed)
- Patients with other coexistent rheumatologic diseases.
- Patients who have previously received anti TNF alpha agents in the past 1 year.
- Patients who are receiving other medications that may significantly alter the bone metabolism (like steroids, bisphosphonates, estrogen replacement therapy etc)
- Patients with any contraindications against the usage of anti TNF alpha agents (Active/ chronic infections, liver dysfunction, demyelinating diseases, pregnancy etc)
- Patients with other definite risk factors for osteoporosis like chronic alcoholism, smoking, endocrine disorders etc
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 |
|---|---|---|
| anti TNF alpha agentAlso: Infliximab - REMICADE as brand name, Etanercept- ENBREL as brand nameAnti TNF alpha therapy included either INFLIXIMAB or ETANERCEPY Infliximab at 3-5 mg/kg at recommended protocols for the duration of the study Etanercept at 50mg weekly for the duration of the study | Drug | Anti TNF |
| Anti TNF alpha therapyAlso: REMICADE-infliximab, ENBREL-EtanerceptInfliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year | Drug | Anti TNF |
Primary outcome
Increase in bone mineral density and decrease in disease activity
Time frame: 2 years
1 secondary outcome
Observation of adverse effects of Anti TNF therapy
Time frame: 2 years
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 2012.
- Results publication: PubMed 15517638Franck H, Meurer T, Hofbauer LC. Evaluation of bone mineral density, hormones, biochemical markers of bone metabolism, and osteoprotegerin serum levels in patients with ankylosing spondylitis. J Rheumatol. 2004 Nov;31(11):2236-41.
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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.
Surendra K Sharma, MD, PhD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti TNF alpha agent and Anti TNF alpha therapy in people with Ankylosing Spondylitis, run by All India Institute of Medical Sciences at 1 site in India.
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 4 inclusion and 5 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 2012. 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 India. 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?
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?
Increase in bone mineral density and decrease in disease activity (time frame: 2 years). 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 NCT01361542, which also lists 1 linked publication.
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 2012.