Ankylosing SpondylitisPhase 2/3NCT00432653
Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis
A Phase 2/3 study testing rituximab in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to severe ankylosing spondylitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- rituximab
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2007to Nov 2009
- Phase
- Phase 2/3
- 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 - 65 years of age who have moderate to severe ankylosing spondylitis.
- Active disease is defined as a BASDAI score of ³ 4 plus a
- back pain score (BASDAI question 2) of ³ 4 despite concurrent NSAID therapy, or intolerance to NSAIDs
- If on prednisone, £10 mg per day must be stable for 4 weeks prior to baseline.
- If on methotrexate, £ 25 mg per week must be stable for 4 weeks prior to baseline
- If on sulfasalazine, must be stable 4 weeks prior to basline
Show all 9Show fewer
- Women of child bearing potential must have a negative pregnancy urine test at study baseline and use an adequate, effective method of contraception (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner) for a duration of 12 months after stop of rituximab therapy.
- Sexual active men must use an accepted method of contraception for a duration of 12 months after first administration of rituximab.
- Willingness and capability to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study
Who cannot join
- Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus,Sjögren's syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome
- Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
- Primary or secondary immunodeficiency
- History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
- A history of pulmonary or cardiac insufficiency, or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease ( e.g. heart failure class III/IV NYHA, cardiac infarct within last 6 month), nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
Show all 34Show fewer
- Neuropathy that can interfere with quality of life and/or pain assessment.
- Patients with a history of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- History of current evidence of abuse of "hard" drugs (e.g. cocaine/ heroine) or alcoholism
- Known hypersensitivity to any component of the product or to murine proteins (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, HCl).
- Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)
- Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier) for up to 12.5 months after first infusion of rituximab
- History of alcohol, drug or chemical abuse within 6 month prior to screening
- Lack of peripheral venous access
- Obligatory indication for initiation of established therapy, e.g. with TNFalpha-inhibitors
- If on leflunomide, leflunomide must have been terminated at least 8 weeks prior to the first rituximab infusion (or ≥ 28 days after 11 days of standard cholestyramine or activated charcoal washout).
- If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFa therapy must have been terminated at least 4 weeks prior to the first rituximab infusion if etanercept was used and at least 8 weeks if infliximab or adalimumab were used
- Previous treatment with rituximab or intolerance to rituximab
- Corticosteroids at doses exceeding 10 mg per day of prednisolone or the equivalent within the last 4 weeks prior to the first rituximab infusion
- Intolerance or contraindication to drugs required for the treatment of the side effects of rituximab (e.g. paracetamol, acetaminophen, diphenhydramine, p.o. and i.v. corticosteroids, anti-emetics or H1 blockers
- Previous treatment with any investigational agent
- Previous treatment with i.v. immunoglobulins
- Receipt of a live vaccine within 4 weeks prior to treatment
- Intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit
- Haemoglobin < 8.5 g/dl
- Neutrophil counts < 2.000 / µl
- Platelet count < 125.000 / µl
- Lower than 1 x 1000/µl lymphopenia for more than three months prior to inclusion.
- Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal
- Positive HIV, hepatitis B or C serology
- Patients who participate currently in another clinical trial or patients who participated in another clinical trial during the last 30 days.
- Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
- Patients who are institutionalised due to regulatory or juridical order (according to AMG § 40 (1) Abs. 4)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology
Berlin, 12200
Joachim Sieper, MD; Prof., 0049-30-8445 ext. 4547, joachim.sieper@charite.de
In-Ho Song, MD, 0049-30-8445 ext. 4795, in-ho.song@charite.de
Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus
Herne, 44652
Juergen Braun, MD, Prof., 0049-232559 ext. 2138, j.braun@rheumazentrum-ruhrgebiet.de
Annette Tengelmann, 0049-232559 ext. 2138, tengelmann@rheumazentrum-ruhrgebiet.de
About this study
To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to severe ankylosing spondylitis
Read the detailed description
Indication: Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitors.
Rationale: We have argued already 10 years ago that autoimmunity plays an important role in the pathogenesis of ankylosing spondylitis (AS). Although there is no direct evidence, as in nearly all 'suspected' autoimmune diseases, of an autoimmune response in AS it has been proposed repeatedly over the last years that the cartilage is the most likely target of an autoimmune response in AS. Histological studies 4,5 and magnet resonance imaging investigations suggest that the primary site of inflammation is the cartilage/bone interphase. Mononuclear cell infiltrates are mainly found in cartilage and the subchondral bone. In early and active sacroiliitis, T cells and macrophages are dominant in these infiltrates underlining the relevance of a specific cellular immune response 5.Furthermore, T cell responses have been demonstrated against proteoglycan (an important cartilage protein) in human arthritides including ankylosing spondylitis. We could also recently demonstrate both a CD4+ and a CD8+ T cell response to proteogkycan (aggrecan) derived peptides in the peripheral blood and a CD8+ T cell response against a collagen VI derived peptide in the synovial fluid from AS patients. Thus, all these findings suggest that a chronic, probably T cell mediated, immune response against cartilage is relevant in the pathogenesis of AS.This was further backed by recent studies from our group demonstrating mononuclear infiltrates of cartilage by investigating femoral heads and facette joints (small joints of the spine) obtained by surgery from a number of AS patients). The presence of mononuclear cell infiltrates was strongly dependent on the presence of cartilage on the surface of the femoral heads, suggesting that cartilage could be indeed the stimulus and target of a cellular immune response. However, rather surprisingly there were also dense infiltrations of B cells in the subchondral bone marrow in these patients. In comparison to immunohistological stainings from controls without spinal disease, the number of B cells in AS was even higher than the T cells. At the moment it is not clear whether this indicates that autoantibodies do play a role in the pathogenesis or whether these B cells might rather act as important local antigen presenting cells. In any case, given the assumed autoimmune pathogenesis in AS and the presence of B cells aggregates in inflammatory cellular infiltrates the study of potential effects of an immunotherapy which targets B cells in AS is justified and needed.
Objectives: To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to severe ankylosing spondylitis.
Study design: Open label clinical trial with a study duration of 48 weeks
- Conditions
- Ankylosing Spondylitis
- Being tested
- rituximab
- Keywords
- ankylosing spondylitis, rituximab, therapy, magnetic resonance imaging
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation in week 24 and until study end: ASAS 20 in AS patients naïve to TNFalpha inhibitors as well as in AS patients with previous therapy with TNFalpha inhibitors.
Secondary outcomes (20)
Safety Evaluations (Adverse events, vital signs, physical examination results, and clinical laboratory values until week 48)
Efficacy Evaluations:
ASAS 40 response
ASAS criteria for partial remission
Duration of response
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-36Numeric Rating Scale (NRS)
physicians global
patients global
general pain
nocturnal pain Enthesitis index (Maastricht scale
swollen joint countEQ-5D
Socio-economic questionnairecourse of change of active and chronic inflammatory lesions in MRI after 24 weeks and after 48 weeksB cell analysis and T cell analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startMar 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Joachim Sieper, MD, Prof., Principal investigator, Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432653
- Sponsor's protocol ID
- Ritux-AS-01
- Status last verified
- Feb 2007
- First submitted
- 6 Feb 2007
- Last updated
- 8 Feb 2007
- Results posted
- No
Publications
Sieper J, Braun J. Pathogenesis of spondylarthropathies. Persistent bacterial antigen, autoimmunity, or both? Arthritis Rheum. 1995 Nov;38(11):1547-54. doi: 10.1002/art.1780381105.
PubMed 7488274Appel H, Loddenkemper C, Grozdanovic Z, Ebhardt H, Dreimann M, Hempfing A, Stein H, Metz-Stavenhagen P, Rudwaleit M, Sieper J. Correlation of histopathological findings and magnetic resonance imaging in the spine of patients with ankylosing spondylitis. Arthritis Res Ther. 2006;8(5):R143. doi: 10.1186/ar2035.
PubMed 16925803Appel H, Kuhne M, Spiekermann S, Ebhardt H, Grozdanovic Z, Kohler D, Dreimann M, Hempfing A, Rudwaleit M, Stein H, Metz-Stavenhagen P, Sieper J, Loddenkemper C. Immunohistologic analysis of zygapophyseal joints in patients with ankylosing spondylitis. Arthritis Rheum. 2006 Sep;54(9):2845-51. doi: 10.1002/art.22060.
PubMed 16947385Zochling J, van der Heijde D, Burgos-Vargas R, Collantes E, Davis JC Jr, Dijkmans B, Dougados M, Geher P, Inman RD, Khan MA, Kvien TK, Leirisalo-Repo M, Olivieri I, Pavelka K, Sieper J, Stucki G, Sturrock RD, van der Linden S, Wendling D, Bohm H, van Royen BJ, Braun J; 'ASsessment in AS' international working group; European League Against Rheumatism. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006 Apr;65(4):442-52. doi: 10.1136/ard.2005.041137. Epub 2005 Aug 26.
PubMed 16126791Edwards JC, Szczepanski L, Szechinski J, Filipowicz-Sosnowska A, Emery P, Close DR, Stevens RM, Shaw T. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004 Jun 17;350(25):2572-81. doi: 10.1056/NEJMoa032534.
PubMed 15201414Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, Racewicz AJ, van Vollenhoven RF, Li NF, Agarwal S, Hessey EW, Shaw TM; DANCER Study Group. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006 May;54(5):1390-400. doi: 10.1002/art.21778.
PubMed 16649186Sieper J, Baraliakos X, Listing J, Brandt J, Haibel H, Rudwaleit M, Braun J. Persistent reduction of spinal inflammation as assessed by magnetic resonance imaging in patients with ankylosing spondylitis after 2 yrs of treatment with the anti-tumour necrosis factor agent infliximab. Rheumatology (Oxford). 2005 Dec;44(12):1525-30. doi: 10.1093/rheumatology/kei046. Epub 2005 Aug 9.
PubMed 16091396Song IH, Heldmann F, Rudwaleit M, Listing J, Appel H, Braun J, Sieper J. Different response to rituximab in tumor necrosis factor blocker-naive patients with active ankylosing spondylitis and in patients in whom tumor necrosis factor blockers have failed: a twenty-four-week clinical trial. Arthritis Rheum. 2010 May;62(5):1290-7. doi: 10.1002/art.27383.
PubMed 20461780
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00432653
- Acronym / sponsor ID
- Ritux-AS-01
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, rituximab, therapy, magnetic resonance imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Mar 2007
- Study completion
- Nov 2009
- First posted
- 8 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.
To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to severe ankylosing spondylitis
Detailed description
Indication: Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitors.
Rationale: We have argued already 10 years ago that autoimmunity plays an important role in the pathogenesis of ankylosing spondylitis (AS). Although there is no direct evidence, as in nearly all 'suspected' autoimmune diseases, of an autoimmune response in AS it has been proposed repeatedly over the last years that the cartilage is the most likely target of an autoimmune response in AS. Histological studies 4,5 and magnet resonance imaging investigations suggest that the primary site of inflammation is the cartilage/bone interphase. Mononuclear cell infiltrates are mainly found in cartilage and the subchondral bone. In early and active sacroiliitis, T cells and macrophages are dominant in these infiltrates underlining the relevance of a specific cellular immune response 5.Furthermore, T cell responses have been demonstrated against proteoglycan (an important cartilage protein) in human arthritides including ankylosing spondylitis. We could also recently demonstrate both a CD4+ and a CD8+ T cell response to proteogkycan (aggrecan) derived peptides in the peripheral blood and a CD8+ T cell response against a collagen VI derived peptide in the synovial fluid from AS patients. Thus, all these findings suggest that a chronic, probably T cell mediated, immune response against cartilage is relevant in the pathogenesis of AS.This was further backed by recent studies from our group demonstrating mononuclear infiltrates of cartilage by investigating femoral heads and facette joints (small joints of the spine) obtained by surgery from a number of AS patients). The presence of mononuclear cell infiltrates was strongly dependent on the presence of cartilage on the surface of the femoral heads, suggesting that cartilage could be indeed the stimulus and target of a cellular immune response. However, rather surprisingly there were also dense infiltrations of B cells in the subchondral bone marrow in these patients. In comparison to immunohistological stainings from controls without spinal disease, the number of B cells in AS was even higher than the T cells. At the moment it is not clear whether this indicates that autoantibodies do play a role in the pathogenesis or whether these B cells might rather act as important local antigen presenting cells. In any case, given the assumed autoimmune pathogenesis in AS and the presence of B cells aggregates in inflammatory cellular infiltrates the study of potential effects of an immunotherapy which targets B cells in AS is justified and needed.
Objectives: To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to severe ankylosing spondylitis.
Study design: Open label clinical trial with a study duration of 48 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients 18 - 65 years of age who have moderate to severe ankylosing spondylitis.
- Active disease is defined as a BASDAI score of ³ 4 plus a
- back pain score (BASDAI question 2) of ³ 4 despite concurrent NSAID therapy, or intolerance to NSAIDs
- If on prednisone, £10 mg per day must be stable for 4 weeks prior to baseline.
- If on methotrexate, £ 25 mg per week must be stable for 4 weeks prior to baseline
Key exclusion criteria (34 listed)
- Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus,Sjögren's syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome
- Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
- Primary or secondary immunodeficiency
- History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
- A history of pulmonary or cardiac insufficiency, or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
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 |
|---|---|---|
| rituximab | Drug | – |
Primary outcome
Evaluation in week 24 and until study end: ASAS 20 in AS patients naïve to TNFalpha inhibitors as well as in AS patients with previous therapy with TNFalpha inhibitors.
20 secondary outcomes
Safety Evaluations (Adverse events, vital signs, physical examination results, and clinical laboratory values until week 48)
Efficacy Evaluations:
ASAS 40 response
ASAS criteria for partial remission
Duration of response
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-36Numeric Rating Scale (NRS)
physicians global
patients global
general pain
nocturnal pain Enthesitis index (Maastricht scale
swollen joint countEQ-5D
Socio-economic questionnairecourse of change of active and chronic inflammatory lesions in MRI after 24 weeks and after 48 weeksB cell analysis and T cell analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2007.
- Background: PubMed 7488274Sieper J, Braun J. Pathogenesis of spondylarthropathies. Persistent bacterial antigen, autoimmunity, or both? Arthritis Rheum. 1995 Nov;38(11):1547-54. doi: 10.1002/art.1780381105.
- Background: PubMed 16925803Appel H, Loddenkemper C, Grozdanovic Z, Ebhardt H, Dreimann M, Hempfing A, Stein H, Metz-Stavenhagen P, Rudwaleit M, Sieper J. Correlation of histopathological findings and magnetic resonance imaging in the spine of patients with ankylosing spondylitis. Arthritis Res Ther. 2006;8(5):R143. doi: 10.1186/ar2035.
- Background: PubMed 16947385Appel H, Kuhne M, Spiekermann S, Ebhardt H, Grozdanovic Z, Kohler D, Dreimann M, Hempfing A, Rudwaleit M, Stein H, Metz-Stavenhagen P, Sieper J, Loddenkemper C. Immunohistologic analysis of zygapophyseal joints in patients with ankylosing spondylitis. Arthritis Rheum. 2006 Sep;54(9):2845-51. doi: 10.1002/art.22060.
- Background: PubMed 16126791Zochling J, van der Heijde D, Burgos-Vargas R, Collantes E, Davis JC Jr, Dijkmans B, Dougados M, Geher P, Inman RD, Khan MA, Kvien TK, Leirisalo-Repo M, Olivieri I, Pavelka K, Sieper J, Stucki G, Sturrock RD, van der Linden S, Wendling D, Bohm H, van Royen BJ, Braun J; 'ASsessment in AS' international working group; European League Against Rheumatism. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006 Apr;65(4):442-52. doi: 10.1136/ard.2005.041137. Epub 2005 Aug 26.
- Background: PubMed 15201414Edwards JC, Szczepanski L, Szechinski J, Filipowicz-Sosnowska A, Emery P, Close DR, Stevens RM, Shaw T. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004 Jun 17;350(25):2572-81. doi: 10.1056/NEJMoa032534.
- Background: PubMed 16649186Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, Racewicz AJ, van Vollenhoven RF, Li NF, Agarwal S, Hessey EW, Shaw TM; DANCER Study Group. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006 May;54(5):1390-400. doi: 10.1002/art.21778.
- Background: PubMed 16091396Sieper J, Baraliakos X, Listing J, Brandt J, Haibel H, Rudwaleit M, Braun J. Persistent reduction of spinal inflammation as assessed by magnetic resonance imaging in patients with ankylosing spondylitis after 2 yrs of treatment with the anti-tumour necrosis factor agent infliximab. Rheumatology (Oxford). 2005 Dec;44(12):1525-30. doi: 10.1093/rheumatology/kei046. Epub 2005 Aug 9.
- Derived from this study: PubMed 20461780Song IH, Heldmann F, Rudwaleit M, Listing J, Appel H, Braun J, Sieper J. Different response to rituximab in tumor necrosis factor blocker-naive patients with active ankylosing spondylitis and in patients in whom tumor necrosis factor blockers have failed: a twenty-four-week clinical trial. Arthritis Rheum. 2010 May;62(5):1290-7. doi: 10.1002/art.27383.
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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, Prof. principal investigator
Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rituximab in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 2 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 9 inclusion and 34 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 8 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 In-Ho Song, MD (0049-30-8445 ext. 4895, in-ho.song@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation in week 24 and until study end: ASAS 20 in AS patients naïve to TNFalpha inhibitors as well as in AS patients with previous therapy with TNFalpha inhibitors.. 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 NCT00432653, which also lists 8 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 8 Feb 2007.