Ankylosing SpondylitisPhase 4NCT00247962
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
A Phase 4 study testing etanercept and sulphasalazine (SSZ) in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 83 sites in 18 countries.
Trial summary
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- etanercept and sulphasalazine (SSZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 83 sitesin 18 countries
- Study dates
- Dec 2005to Feb 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ankylosing spondylitis
- Active ankylosing spondylitis
Who cannot join
- Complete ankylosis of spine
- Previous treatment with etanercept
Trial locations and contacts
83 sites in 18 countries.
83 sites in 18 countries
Germany13 sites
Study site
Berlin, 12200
Study site
Berlin, D-10117
Study site
Erlangen, D-91054
Study site
Gommern, D-39245
Study site
Hamburg, D-22081
Study site
Herne, D-44652
Study site
Heubnerweg, D-14059
Study site
Hildesheim, D-31134
Study site
München, D-80639
Study site
Pirna, D-01796
Study site
Ratingen, D-40882
Study site
Wiesbaden, 65185
Study site
Wiesbaden, D-65191
France9 sites
Study site
Amiens, 80054
Study site
Bordeaux, 33076
Study site
Boulogne-Billancourt, 92104
Study site
Créteil, 94010
Study site
Marseille, 13005
Study site
Nantes, 44000
Study site
Orléans, 45032
Study site
Pierre Mendès, 76290
Study site
Toulouse, 31059
Italy9 sites
Study site
Benevento, 82037
Study site
Bergamo, 24128
Study site
Florence, 50143
Study site
Monserrato, 09042
Study site
Potenza, 85100
Study site
Prato, 59100
Study site
Reggio Emilia, 42100
Study site
Roma, 00161
Study site
Roma, 00189
Spain8 sites
Study site
Asturias, 33012
Study site
Barcelona, 08003
Study site
Córdoba, 14004
Study site
Granollers, Barcelona, 08400
Study site
Madrid, 28035
Study site
Madrid, 28922
Study site
Porto, 4200-319
Study site
Santa Cruz de Tenerife, 38010
United Kingdom8 sites
Study site
Basingstoke, RG24 9NA
Study site
Cambridge, CB2 2QQ
Study site
Cannock, WS11 2XY
Study site
Glasgow, G31 2ER
Study site
Liverpool, L9 7AL
Study site
Newcastle upon Tyne, NE7 7DN
Study site
Upper Borough Walls, BA1 1RL
Study site
Upton, Wirral, L49 5PE
Hungary5 sites
Study site
Debrecen, 4043
Study site
Győr, 9025
Study site
Nyíregyháza, 4400
Study site
Pécs, 7621
Study site
Szeged, 6724
Netherlands5 sites
Study site
Amsterdam, 1081 HV
Study site
Groningen, 9713GZ
Study site
Leeuwarden, 8934AD
Study site
Maastricht, 6229HX
Study site
Nijmegen, 6522JV
Denmark4 sites
Study site
Frederiksberg, DK-2000
Study site
Kolding, 6000
Study site
Odense, 5000
Study site
Vejle, 7100
Poland4 sites
Study site
Lodz, 93-513
Study site
Ustron Zawodzie, 43-450
Study site
Warsaw, 02-637
Study site
Wroclaw, 53-137
Austria3 sites
Study site
Innsbruck, 6020
Study site
Klagenfurt, A-9020
Study site
Linz, A-4020
Finland3 sites
Study site
Helsinki, 00029
Study site
Kuopio, 70211
Study site
Tampere, 33100
Australia2 sites
Study site
Heidelberg West, Victoria, 3081
Study site
Shenton Park, Western Australia, 6000
About this study
Official title: A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- etanercept, sulphasalazine (SSZ)
- Keywords
- Ankylosing Spondylitis (AS)
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
50 mg
sulphasalazine (SSZ)Drug
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: etanercept |
| B | Active comparator | Not described Receives: Drug: sulphasalazine (SSZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Measured: 16 weeks
Secondary outcomes (1)
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
Measured: Baseline and 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Poland, WPWZMED@wyeth.comTrial Manager, Principal investigator, For Italy, descresg@wyeth.comTrial Manager, Principal investigator, For Hungary, WPBUMED@wyeth.comTrial Manager, Principal investigator, For Czech Republic, WPPGCLI@wyeth.comTrial Manager, Principal investigator, For Australia, medinfo@wyeth.comTrial Manager, Principal investigator, For Germany, medinfoDEU@wyeth.comTrial Manager, Principal investigator, For Austria, WPVIMED@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247962
- Sponsor's protocol ID
- 0881A3-402
- Status last verified
- Oct 2012
- First submitted
- 31 Oct 2005
- Last updated
- 8 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.
PubMed 38488976Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.
PubMed 30473179Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. J Rheumatol. 2012 Apr;39(4):836-40. doi: 10.3899/jrheum.110885. Epub 2012 Feb 15.
PubMed 22337244Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Arthritis Rheum. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223.
PubMed 21630245
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00247962
- Acronym / sponsor ID
- 0881A3-402
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis (AS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Posted 8 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: etanercept |
| B | Active comparator | Drug: sulphasalazine (SSZ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of ankylosing spondylitis
- Active ankylosing spondylitis
Key exclusion criteria (2 listed)
- Complete ankylosis of spine
- Previous treatment with etanercept
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 |
|---|---|---|
| etanercept50 mg | Drug | A |
| sulphasalazine (SSZ)Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study. | Drug | B |
Primary outcome
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
Time frame: 16 weeks
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
1 secondary outcome
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Time frame: Baseline and 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38488976Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.
- Derived from this study: PubMed 30473179Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.
- Derived from this study: PubMed 22337244Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. J Rheumatol. 2012 Apr;39(4):836-40. doi: 10.3899/jrheum.110885. Epub 2012 Feb 15.
- Derived from this study: PubMed 21630245Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Arthritis Rheum. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223.
Related trials for Ankylosing 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
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Poland, WPWZMED@wyeth.com
Trial Manager principal investigator
For Italy, descresg@wyeth.com
83 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etanercept and sulphasalazine (SSZ) in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 83 sites in 18 countries.
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 2 inclusion and 2 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 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in Germany, France, Italy, Spain, United Kingdom and 13 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) (time frame: 16 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 NCT00247962, 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 8 Nov 2012.