SpondyloarthropathyNCT02948608
Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis
An observational study of Spondyloarthropathy, run by Svendborg Hospital at 1 site in Denmark.
Trial summary
The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondyloarthropathy
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 30 Sep 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ≥ 18 years and diagnosed with any disease of the SpA spectrum, and about to initiate or switch biological treatment. We use the Assessment of Spondyloarthritis International Society (ASAS) criteria for SpA, and the Modified New York criteria for ankylosing spondylitis
Who may be able to join
- Patients diagnosed with SpA
- ≥18 years of age at time of consent
- Ability and willingness to give written informed consent and to meet the requirements of this protocol
- Patients must have a history of active disease and a BASDAI >40 (10-100) or elevated C-reactive protein, despite current or previous NSAIDs therapy
Who cannot join
- Age < 18 years
- No consent
- Pregnancy
- Active or latent TB
- Diagnosed Human immunodeficiency virus
- Diagnosed hepatitis
Show all 10Show fewer
- Current or past malignant disease
- Recurrent or chronic infection (viral, fungal or bacterial)
- Multiple sclerosis
- Heart failure (NYHA class III/IV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents
The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.
Read the detailed description
Patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an active disease state, will be enrolled in this observational study.
The overall aim is to investigate extra-articular manifestations, pain mechanisms and patient-reported outcomes and elucidate if these factors - independently or by interaction - influence treatment response after ≥ 3 months. Patients will have a baseline visit, an eye examination and a follow up visit after ≥ 3 months. Clinical examinations will be performed at both time points and include:
- Clinical examination (the spinal movement)
- Assessment of pain mechanisms by clinical evaluation (BASDAI, tender points,) and pain questionnaires (PainDETECT).
- The SPARCC Enthesitis Index will be used to enthesitis count.
- Interview and questionnaires regarding lifestyle, comorbidity, function and quality of life
- Blood samples
- Urine samples
- Stool samples
Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of extra-articular manifestations, comorbidity and pain mechanisms will be analysed.
- Conditions
- Spondyloarthropathy
- Keywords
- spondyloarthropathy, ankylosing spondylitis, spinal diseases, spondylitis, spondylarthritis, psoriasis, uveitis, joint diseases
- Medical subject headings
- Spondylarthropathies, Spondylitis, Ankylosing, Spinal Diseases, Spondylitis, Spondylarthritis, Psoriasis, Uveitis, Joint Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankylosing Spondylitis Disease Activity Index BASDAI 50 %
composite measures of improvement in disease state (50% improvement)
Measured: ≥ 3 month from baseline
Secondary outcomes (1)
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)
composite measures of improvement in disease state
Measured: ≥ 3 month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start1 Mar 2017
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
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 SpondyloarthropathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Svendborg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Parker Research Institute, Spine Centre of Southern Denmark
- Responsible party
- Principal investigator, Rikke Asmussen Andreasen, Svendborg Hospital
- Investigators
- Inger Marie J Hansen, MD, DmSci, Study chair, Svendborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948608
- Sponsor's protocol ID
- S-20160094
- Other IDs
- R-144-A4136
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Andreasen RA, Kristensen LE, Ellingsen T, Christensen R, Baraliakos X, Wied J, Aalykke C, Ulstrup T, Schiottz-Christensen B, Horn HC, Emamifar A, Duerlund B, Fischer L, Hansen IMJ. Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study. BMJ Open. 2017 Jul 10;7(7):e015536. doi: 10.1136/bmjopen-2016-015536.
PubMed 28698330
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents
- ClinicalTrials.gov ID
- NCT02948608
- Acronym / sponsor ID
- S-20160094
- Conditions
- Spondyloarthropathy
- Keywords
- spondyloarthropathy, ankylosing spondylitis, spinal diseases, spondylitis, spondylarthritis, psoriasis, uveitis, joint diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Svendborg HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, Parker Research Institute, Spine Centre of Southern Denmark
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 28 Oct 2016 (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.
The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.
Detailed description
Patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an active disease state, will be enrolled in this observational study.
The overall aim is to investigate extra-articular manifestations, pain mechanisms and patient-reported outcomes and elucidate if these factors - independently or by interaction - influence treatment response after ≥ 3 months. Patients will have a baseline visit, an eye examination and a follow up visit after ≥ 3 months. Clinical examinations will be performed at both time points and include:
- Clinical examination (the spinal movement)
- Assessment of pain mechanisms by clinical evaluation (BASDAI, tender points,) and pain questionnaires (PainDETECT).
- The SPARCC Enthesitis Index will be used to enthesitis count.
- Interview and questionnaires regarding lifestyle, comorbidity, function and quality of life
- Blood samples
- Urine samples
- Stool samples
Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of extra-articular manifestations, comorbidity and pain mechanisms will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ≥ 18 years and diagnosed with any disease of the SpA spectrum, and about to initiate or switch biological treatment. We use the Assessment of Spondyloarthritis International Society (ASAS) criteria for SpA, and the Modified New York criteria for ankylosing spondylitis
Key inclusion criteria (4 listed)
- Patients diagnosed with SpA
- ≥18 years of age at time of consent
- Ability and willingness to give written informed consent and to meet the requirements of this protocol
- Patients must have a history of active disease and a BASDAI >40 (10-100) or elevated C-reactive protein, despite current or previous NSAIDs therapy
Key exclusion criteria (10 listed)
- Age < 18 years
- No consent
- Pregnancy
- Active or latent TB
- Diagnosed Human immunodeficiency virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ankylosing Spondylitis Disease Activity Index BASDAI 50 %
Time frame: ≥ 3 month from baseline
composite measures of improvement in disease state (50% improvement)
1 secondary outcome
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: ≥ 3 month from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 28698330Andreasen RA, Kristensen LE, Ellingsen T, Christensen R, Baraliakos X, Wied J, Aalykke C, Ulstrup T, Schiottz-Christensen B, Horn HC, Emamifar A, Duerlund B, Fischer L, Hansen IMJ. Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study. BMJ Open. 2017 Jul 10;7(7):e015536. doi: 10.1136/bmjopen-2016-015536.
- Individual participant dataSharing planned: No
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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.
Inger Marie J Hansen, MD, DmSci study chair
Svendborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthropathy, run by Svendborg Hospital at 1 site in Denmark.
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 10 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 7 Mar 2019. 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 Denmark. 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?
Results are not available in the source record.
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?
Ankylosing Spondylitis Disease Activity Index BASDAI 50 % (time frame: ≥ 3 month from baseline). 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 NCT02948608, 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 7 Mar 2019.