Moderate to Severe Active Axial SpondyloarthritisPhase 2NCT00844142
Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)
A Phase 2 study testing Etanercept 25mg and Sulfasalazine in people with Moderate to Severe Active Axial Spondyloarthritis, run by Charite University, Berlin, Germany at 9 sites in Germany.
Trial summary
Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate to Severe Active Axial Spondyloarthritis
- What is being tested?
- Etanercept 25mg and Sulfasalazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesGermany
- Study dates
- Nov 2005to Jul 2013
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 - 50 years of age who have moderate to severe active axial spondyloarthritis.
- Diagnosis made by :Chronic low back pain (duration > 3 months, onset < 45 years of age)plus 3 out of the 6 following criteria if imaging is positive or 4 out of the following 6 criteria if imaging is negative ·
- Inflammatory back pain:
- Good or very good response to NSAIDs
- One or more of the following extraspinal manifestations: uveitis, peripheral arthritis, enthesitis, HLA-B27 positive
- Positive imaging: MRI showing acute inflammatory lesions in spine or SIJ (in the past) or bilateral sacroiliitis grade 2-4 or unilateral sacroiliitis grade 3-4 in x-ray not older than 12 months
Show all 18Show fewer
- Positive family history for SpA
- MRI at screening showing acute inflammatory lesions in SIJ or spine
- Active disease is defined as:
- a BASDAI score of >=4
- back pain score (BASDAI question 2) of >= 4 despite concurrent NSAID therapy, or intolerance to NSAIDs.
- Other inclusion criteria include, if on prednisone:
- <7.5 mg per day
- stable for 4 weeks prior to baseline
- Women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate, effective method of contraception for a duration of 6 months after stop of etanercept therapy. Sexual active men must use an accepted method of contraception for a duration of 6 months after stop of etanercept therapy.
- Reading a normal chest/lung x-ray which should have been performed within the last 12 weeks before inclusion
- Able to self-administer injectable drug supplies or have a caregiver who will do so.
- Able to store injectable test article at 2° to 8° C.
Who cannot join
- Disease duration of longer than 5 years
- History of active tuberculosis (TB), histoplasmosis or listeriosis.
- History of positive HIV status, known hepatitis B or C
- History of malignancy other than carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma.
- Antibiotic treatment within 3 weeks prior to screening.
- Previous treatment with TNF-alpha blockers
- Treatment with sulasalazine in the last 6 months before participation in the clinical trial
- severe internal medical diseases such as severe cardiac, hepatic, gastrointestinal, neurological, psychiatric diseases
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites, 9 recruiting
- Recruiting
Charité Campus Mitte, Rheumatology
Berlin, 10117
Gerd-Ruediger Burmester, MD, 0049-30-450513 ext. 025, gerd.burmester@charite.de
- Recruiting
Praxis Mielke
Berlin, 12627
Mielke, MD, 0049-30-994 ext. 21 22
- Recruiting
Praxis Zinke
Berlin, 13055
Silke Zinke, MD, 0049-30-98695 ext. 231, dr.silke.zinke@t-online.de
- Recruiting
Klinikum Buch
Berlin, 13125
Andreas Krause, MD, 0049-30-94792 ext. 380, a.krause@immanuel.de
- Recruiting
Waldkrankenhaus
Berlin, 13589
Ulrich Prothmann, MD, 0049-30-3702- ext. 1302, u.prothmann@waldkrankenhaus.com
- Recruiting
Schlossparkklinik, Rheumatology
Berlin, 14059
Rieke Alten, MD, 0049-303264- ext. 1333, rieke.alten@schlosspark-klinik.de
- Recruiting
Immanuel Krankenhaus
Berlin, 14109
Andreas Krause, MD, 0049-30-80505- ext. 293, a.krause@immanuel.de
- Recruiting
Praxis Klopsch
Neubrandenburg, 17033
Thilo Klopsch, MD, 0049-395- 775 ext. 43 24, dr.thilo.klopsch@t-online.de
- Recruiting
Praxis Bohl-Bühler
Potsdam, 14469
Martin Bohl-Bühler, MD, 0049-331- 647352 ext. 1, info@Rheumahaus.de
About this study
Official title: Randomized Controlled 12 Months Trial With Etanercept (Enbrel ®) vs. Sulfasalazine in Early Axial Spondyloarthritis With Focus on Improvement of Acute Inflammatory Lesions as Detected by MRI. Amendment 4: 1-Year Extension of Study
Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.
Read the detailed description
Randomized controlled study with two treatment arms (Phase II), 1 year open extension
Efficacy - To assess efficacy of etanercept vs. sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned. For etanercept group: To assess whether etanercept will show sustained long term response over 1 more year. To assess whether etanercept will slow or stop progression as shown by MRI.For sulfasalazine group: to assess whether etanercept will show long term response over 1 year. To assess whether etanercept will slow or stop progression as shown by MRI. For all patients who are in remission the duration of remission will be assessed for a maximum of one year. In case of a flare of the disease these patients will be (re-) treated with etanercept and efficacy will be assessed. Safety - To study the long-term safety of etanercept in patients with moderate to severe active early axial spondyloarthritis compared to patients treated with sulfasalazine over a period of one year.
Patients will be treated for 1 year either with etanercept 2x25mg per week subcutaneously or with sulfasalazine 2g/ day given orally. Following screening and baseline evaluations, patients will be assessed at week 2, 4, 6, 8, 10, 12, 24, 36 and 48. Efficacy and safety measurements will be recorded throughout the entire study. The study will be followed by a 60 weeks follow-up phase after week 48 (end of treatment phase). In case of flare they will be (re-)treated with etanercept for further 60 weeks (until week 108). All patients from the former etanercept group who are not in remission will continue to be treated with etanercept for 60 weeks (weeks 60, 72, 84, 96, 108). All patients from the former sulfasalazine group who are not in remission will be switched to etanercept for 60 weeks (at weeks 50, 54, 60, 72, 84, 96, 108).
Treatment arms:Arm 1: 40 patients receive etanercept 2x25 mg weekly subcutaneous injectionArm 2: 40 patients receive sulfasalazine up to 2 g/day (up to 3 g/ per day)
Duration of the study:12 months. For patients in remission a 12 months follow up period will be enclosed. Treatment will be continued for patients in case of flare or in patients who did not achieve remission for 60 weeks. The study is planned start at September 2005. Patients will be recruited over a 12 months period. Altogether the duration of the study is up to 51 months. All patients who are willing to participate in the extension will be treated for another 60 weeks.
Patient Population:Only active axial SpA patients with a disease duration (measured from time of ongoing spinal symptoms) of less than 5 years will be included. This implies that patients with both radiological evidence of sacroiliitis (fulfilling the modified New York criteria for AS) and without radiological evidence of sacroiliitis (see inclusion criteria) will be included.
Efficacy Variables:Primary endpoint:· Reduction of active inflammatory lesions in MRI at 12 monthsSecondary endpoints:
- ASAS 20%, 40%, 70% response, ASAS criteria for partial remission· BASDAI 20%, 50%, 70% improvement · BASFI · Mobility examinations: BASMI, Chest Wall Expansion· disease controlling antirheumatic therapy criteria (DC-ART20) (5 out of 6)*· CRP, ESR· Quality of Life: SF-36· Numeric Rating Scale (NRS) - physicians global, patients global, general pain, nocturnal pain · Enthesitis index (Maastricht scale)· swollen joint count· EQ-5D· Socio-economic questionnaire· Chronic changes in MRI at 6, 12 months and 108 weeks· Reduction of active inflammatory lesions in MRI at 6 months and chronic lesions at 6 and 12 months and 108 weeks
- Being tested
- Etanercept 25mg, Sulfasalazine
- Keywords
- ankylosing spondylitis, axial spondyloarthritis, magnetic resonance imaging, etanercept, sulfasalazine
- Medical subject headings
- Spondylitis, Ankylosing, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept 25mgDrug
patients will receive etanercept 25mg twice weekly
SulfasalazineDrug
in this arm patients will receive sulfasalazine 2000- 3000mg per os daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | etanercept 25mg twice weekly Receives: Drug: Etanercept 25mg |
| 2 | Active comparator | Sulfasalazine 2000- 3000mg daily Receives: Drug: Sulfasalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Reduction of active inflammatory lesions in MRI at 12 months.
Measured: 108 weeks
Secondary outcomes (1)
Secondary outcome: ASAS 20%, 40%, 70% response, ASAS criteria for partial remission· BASDAI 20%, 50%, 70% improvement · BASFI ·
Measured: 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startNov 2005
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Active Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Joachim Sieper, MD, Principal investigator, Charite, Campus Benjamin-Franklin, Rheumatology, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844142
- Sponsor's protocol ID
- M01
- Other IDs
- Enbrel-Sulfa-Early-AS
- Status last verified
- Feb 2009
- First submitted
- 12 Feb 2009
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torgutalp M, Rademacher J, Proft F, Hermann KG, Althoff C, Haibel H, Protopopov M, Sieper J, Rios Rodriguez V, Poddubnyy D. Association between resolution of MRI-detected inflammation and improved clinical outcomes in axial spondyloarthritis under long-term anti-TNF therapy. RMD Open. 2025 Jan 6;11(1):e004921. doi: 10.1136/rmdopen-2024-004921.
PubMed 39762123Song IH, Hermann KG, Haibel H, Althoff CE, Poddubnyy D, Listing J, Weiss A, Lange E, Freundlich B, Rudwaleit M, Sieper J. Prevention of new osteitis on magnetic resonance imaging in patients with early axial spondyloarthritis during 3 years of continuous treatment with etanercept: data of the ESTHER trial. Rheumatology (Oxford). 2015 Feb;54(2):257-61. doi: 10.1093/rheumatology/keu263. Epub 2014 Aug 19.
PubMed 25140041Song IH, Hermann KG, Haibel H, Althoff CE, Poddubnyy D, Listing J, Weiss A, Buss B, Freundlich B, Lange E, Alten R, Rudwaleit M, Sieper J. Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial. J Rheumatol. 2014 Oct;41(10):2034-40. doi: 10.3899/jrheum.140056. Epub 2014 Jul 15.
PubMed 25028375Weiss A, Song IH, Haibel H, Listing J, Sieper J. Good correlation between changes in objective and subjective signs of inflammation in patients with short- but not long duration of axial spondyloarthritis treated with tumor necrosis factor-blockers. Arthritis Res Ther. 2014 Jan 30;16(1):R35. doi: 10.1186/ar4464.
PubMed 24476416
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled 12 Months Trial With Etanercept (Enbrel ®) vs. Sulfasalazine in Early Axial Spondyloarthritis With Focus on Improvement of Acute Inflammatory Lesions as Detected by MRI. Amendment 4: 1-Year Extension of Study
- ClinicalTrials.gov ID
- NCT00844142
- Acronym / sponsor ID
- M01
- Keywords
- ankylosing spondylitis, axial spondyloarthritis, magnetic resonance imaging, etanercept, sulfasalazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Nov 2005
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 13 Feb 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.
Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.
Detailed description
Randomized controlled study with two treatment arms (Phase II), 1 year open extension
Efficacy - To assess efficacy of etanercept vs. sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned. For etanercept group: To assess whether etanercept will show sustained long term response over 1 more year. To assess whether etanercept will slow or stop progression as shown by MRI.For sulfasalazine group: to assess whether etanercept will show long term response over 1 year. To assess whether etanercept will slow or stop progression as shown by MRI. For all patients who are in remission the duration of remission will be assessed for a maximum of one year. In case of a flare of the disease these patients will be (re-) treated with etanercept and efficacy will be assessed. Safety - To study the long-term safety of etanercept in patients with moderate to severe active early axial spondyloarthritis compared to patients treated with sulfasalazine over a period of one year.
Patients will be treated for 1 year either with etanercept 2x25mg per week subcutaneously or with sulfasalazine 2g/ day given orally. Following screening and baseline evaluations, patients will be assessed at week 2, 4, 6, 8, 10, 12, 24, 36 and 48. Efficacy and safety measurements will be recorded throughout the entire study. The study will be followed by a 60 weeks follow-up phase after week 48 (end of treatment phase). In case of flare they will be (re-)treated with etanercept for further 60 weeks (until week 108). All patients from the former etanercept group who are not in remission will continue to be treated with etanercept for 60 weeks (weeks 60, 72, 84, 96, 108). All patients from the former sulfasalazine group who are not in remission will be switched to etanercept for 60 weeks (at weeks 50, 54, 60, 72, 84, 96, 108).
Treatment arms:Arm 1: 40 patients receive etanercept 2x25 mg weekly subcutaneous injectionArm 2: 40 patients receive sulfasalazine up to 2 g/day (up to 3 g/ per day)
Duration of the study:12 months. For patients in remission a 12 months follow up period will be enclosed. Treatment will be continued for patients in case of flare or in patients who did not achieve remission for 60 weeks. The study is planned start at September 2005. Patients will be recruited over a 12 months period. Altogether the duration of the study is up to 51 months. All patients who are willing to participate in the extension will be treated for another 60 weeks.
Patient Population:Only active axial SpA patients with a disease duration (measured from time of ongoing spinal symptoms) of less than 5 years will be included. This implies that patients with both radiological evidence of sacroiliitis (fulfilling the modified New York criteria for AS) and without radiological evidence of sacroiliitis (see inclusion criteria) will be included.
Efficacy Variables:Primary endpoint:· Reduction of active inflammatory lesions in MRI at 12 monthsSecondary endpoints:
- ASAS 20%, 40%, 70% response, ASAS criteria for partial remission· BASDAI 20%, 50%, 70% improvement · BASFI · Mobility examinations: BASMI, Chest Wall Expansion· disease controlling antirheumatic therapy criteria (DC-ART20) (5 out of 6)*· CRP, ESR· Quality of Life: SF-36· Numeric Rating Scale (NRS) - physicians global, patients global, general pain, nocturnal pain · Enthesitis index (Maastricht scale)· swollen joint count· EQ-5D· Socio-economic questionnaire· Chronic changes in MRI at 6, 12 months and 108 weeks· Reduction of active inflammatory lesions in MRI at 6 months and chronic lesions at 6 and 12 months and 108 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Etanercept 25mgetanercept 25mg twice weekly |
| 2 | Active comparator | Drug: SulfasalazineSulfasalazine 2000- 3000mg daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients 18 - 50 years of age who have moderate to severe active axial spondyloarthritis.
- Diagnosis made by :Chronic low back pain (duration > 3 months, onset < 45 years of age)plus 3 out of the 6 following criteria if imaging is positive or 4 out of the following 6 criteria if imaging is negative ·
- Inflammatory back pain:
- Active disease is defined as:
- Other inclusion criteria include, if on prednisone:
Key exclusion criteria (8 listed)
- Disease duration of longer than 5 years
- History of active tuberculosis (TB), histoplasmosis or listeriosis.
- History of positive HIV status, known hepatitis B or C
- History of malignancy other than carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma.
- Antibiotic treatment within 3 weeks prior to screening.
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 |
|---|---|---|
| Etanercept 25mgpatients will receive etanercept 25mg twice weekly | Drug | 1 |
| Sulfasalazinein this arm patients will receive sulfasalazine 2000- 3000mg per os daily | Drug | 2 |
Primary outcome
Primary outcome: Reduction of active inflammatory lesions in MRI at 12 months.
Time frame: 108 weeks
1 secondary outcome
Secondary outcome: ASAS 20%, 40%, 70% response, ASAS criteria for partial remission· BASDAI 20%, 50%, 70% improvement · BASFI ·
Time frame: 108 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
- Derived from this study: PubMed 39762123Torgutalp M, Rademacher J, Proft F, Hermann KG, Althoff C, Haibel H, Protopopov M, Sieper J, Rios Rodriguez V, Poddubnyy D. Association between resolution of MRI-detected inflammation and improved clinical outcomes in axial spondyloarthritis under long-term anti-TNF therapy. RMD Open. 2025 Jan 6;11(1):e004921. doi: 10.1136/rmdopen-2024-004921.
- Derived from this study: PubMed 25140041Song IH, Hermann KG, Haibel H, Althoff CE, Poddubnyy D, Listing J, Weiss A, Lange E, Freundlich B, Rudwaleit M, Sieper J. Prevention of new osteitis on magnetic resonance imaging in patients with early axial spondyloarthritis during 3 years of continuous treatment with etanercept: data of the ESTHER trial. Rheumatology (Oxford). 2015 Feb;54(2):257-61. doi: 10.1093/rheumatology/keu263. Epub 2014 Aug 19.
- Derived from this study: PubMed 25028375Song IH, Hermann KG, Haibel H, Althoff CE, Poddubnyy D, Listing J, Weiss A, Buss B, Freundlich B, Lange E, Alten R, Rudwaleit M, Sieper J. Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial. J Rheumatol. 2014 Oct;41(10):2034-40. doi: 10.3899/jrheum.140056. Epub 2014 Jul 15.
- Derived from this study: PubMed 24476416Weiss A, Song IH, Haibel H, Listing J, Sieper J. Good correlation between changes in objective and subjective signs of inflammation in patients with short- but not long duration of axial spondyloarthritis treated with tumor necrosis factor-blockers. Arthritis Res Ther. 2014 Jan 30;16(1):R35. doi: 10.1186/ar4464.
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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.
Joachim Sieper, MD principal investigator
Charite, Campus Benjamin-Franklin, Rheumatology, Berlin, Germany
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etanercept 25mg and Sulfasalazine in people with Moderate to Severe Active Axial Spondyloarthritis, run by Charite University, Berlin, Germany at 9 sites in Germany.
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 18 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: status not confirmed, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Joachim Sieper, MD (0049-30-8445 ext. 4535, joachim.sieper@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Reduction of active inflammatory lesions in MRI at 12 months. (time frame: 108 weeks). 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 NCT00844142, which also lists 4 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 13 Feb 2009.