Peripheral SpondylarthritisPhase 3CRESPANCT01426815
Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria
A Phase 3 study testing Golimumab in people with Peripheral Spondylarthritis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this Investigator Initiated study, the investigators want to explore the potential of an induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease stage (less than 3 months of symptom duration) of patients with predominant peripheral spondyloarthritis (SpA), classified according to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Spondylarthritis
- What is being tested?
- Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Mar 2012to 18 Mar 2019
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for study participation if all of the following criteria are met:
- Subject is ≥ 18 years of age
- Subjects must meet the new Assessment of SpondyloArthritis (ASAS) criteria for peripheral spondyloarthritis:
- o Subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis PLUS:
- At least 1 of the following Peripheral Spondyloarthritis (SpA) features:
- Anterior uveitis confirmed by an ophthalmologist(past or present)
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- Crohn's disease or ulcerative colitis diagnosed by a gastroenterologist (past or present)
- Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis 1month before arthritis)
- Psoriasis diagnosed by a dermatologist (past or present)
- Human Leukocyte Antigen (HLA) B27 positivity
- Sacroiliitis by imaging defined as bilateral grade 2-4 or unilateral grade 3-4 sacroiliitis on plain radiographs, according to the modified New York criteria or active sacroiliitis on Magnetic Resonance Imaging (MRI) according to the ASAS consensus definition (ref of addendum)
- Subjects must have had onset of peripheral SpA symptoms ≤ 3 months prior to the screening visit
- Subjects must have active disease at screening and baseline, defined by Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) ≥ 40mm and Patient Global Assessment of Pain VAS ≥ 40mm at screening and baseline visits.
- In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator's clinical judgment.
- Subject has a negative Purified Protein Derivative (PPD) test (or equivalent) and Chest radiography (posteroanterior (PA) and lateral view) at screening. If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction of PPD placement and/or a Chest radiography consistent with prior TB exposure, the subject must initiate, or have documented completions of a course of anti-Tuberculosis therapy.
- Patients must undergo screening for Hepatitis B Virus (HBV) (this includes testing for HBsAg (Hepatitis B surface Antigen), anti-HBs (Hepatitis B surface antibody) and anti-HBc total (Hepatitis B core antibody total).
- Women of childbearing potential or men capable of fathering children must be using adequate birth control measures during the study and for 6 months after receiving the last administration of study agent. Female patients of childbearing potential must test negative for pregnancy.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 6 months after last dose of study drug.
- Examples of approved methods of birth control include the following:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- Oral, parenteral or intravaginal contraceptives for 90 days prior to study drug administration
- A vasectomized partner
- Subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during screening.
- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- Subjects must be able and willing to self-administer sc injections or have a qualified person available to administer subcutaneous injections.
Who cannot join
- Medical history of inflammatory arthritis of a different etiology other than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, or any arthritis with onset prior to age 16 years such as Juvenile idiopathic arthritis (JIA)).
- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy.
- Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to the Baseline Visit.
- Infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline Visit.
- Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
- History of Central Nervous System (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
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- History of listeriosis, histoplasmosis, chronic of active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.
- Have a history of, or concurrent, chronic heart failure, including medically controlled, asymptomatic Congestive Heart Failure (CHF).
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent.
- Positive pregnancy test at screening or baseline.
- Female subjects who are breast-feeding or considering becoming pregnant during the study.
- History of clinically significant drug or alcohol abuse in the last 12 months.
- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
- Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of the normal
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Subject with diagnosis and current symptoms of fibromyalgia.
Trial locations and contacts
1 site in 1 country.
About this study
In this Investigator Initiated study, the investigators want to explore the potential of an induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease stage (less than 3 months of symptom duration) of patients with predominant peripheral spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early ("immature") stage of the disease would result in a significant higher number of patients in clinical remission compared to placebo, and that - comparable to the early Rheumatoid Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to maintain this remission in a number of patients.
In this placebo-controlled, double blind, randomized study (with open-label phase, starting at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2 golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If patients are in 'clinical remission' (clinical remission is defined by the absence of arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In case of clinical relapse, patients will be treated with open-label golimumab 50 mg SC. Patients in sustained clinical remission will be observed to assess the possibility of maintaining drug-free remission. The study duration will be 48 weeks.
- Conditions
- Peripheral Spondylarthritis
- Being tested
- Placebo, Golimumab
- Keywords
- Peripheral spondylarthritis according to ASAS- criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The prefilled syringe with placebo will be administrated subcutaneously every 4 weeks during a study period of 24 weeks.
GolimumabDrug
The prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Golimumab 50mg (Simponi ®) | Experimental | Not described Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
The primary endpoint of the study is the induction of clinical remission (complete resolution of synovitis/dactylitis/enthesitis which was present at baseline) and prevention of newly developing peripheral and/or axial spondylarthritis signs). The primary analysis will be a comparison at 24 weeks of the percentage of patients in clinical remission in the group treated with the Tumor Necrosis Factor (TNF)-blocking agent versus placebo.
Measured: At 24 weeks
Secondary outcomes (6)
The improvement in the tender and swollen joint count
The key secondary endpoint will be the changes in the tender and swollen joint count (76/78 joint count)at 6 months (week 24) in comparison with baseline.
Measured: At week 24.
The improvement in dactylitis with obtaining a circumference measurement and clinical picture.
The key secondary endpoint will be the changes in dactylitis at 6 months (week 24) in comparison with baseline.
Measured: At week 24.
The improvement in enthesitis, using the different scoring systems with inclusion of all relevant entheses.
The key secondary endpoint will be the changes in enthesitis at 6 months (week 24) in comparison with baseline.
Measured: At 24 weeks.
The improvement in global measurements of disease activity.
The improvement in global measurements of disease activity: patient global assessment of disease activity, patient pain assessment (peripheral and axial pain), physician global assessment of disease activity, ...)
Measured: At 24 weeks.
The exploration of the utility of conventional ankylosing spondylitis measurements such as BASDAI, BASFI, BASMI
The key secundairy endpoints will be changes in global measurements of disease activity and conventional ankylosing spondylitis measurements (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI),Bath Ankylosing Spondylitis Metrology Index (BASMI)) at 6 months (week 24) in comparison with baseline.
Measured: At week 24.
The exploration of the safety of (Tumor Necrosis Factor)TNF-α blockade in patients with early peripheral spondyloarthritis.
The improvement in global measurements of disease activity: patient global assessment of disease activity, patient pain assessment (peripheral and axial pain), physician global assessment of disease activity, ...)
Measured: At 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study start13 Mar 2012
- Primary completionMar 2019
- Study completion18 Mar 2019
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 Peripheral SpondylarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Biologics BV
- Responsible party
- Sponsor
- Investigators
- Filip Vandenbosch, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426815
- Sponsor's protocol ID
- 2011/529
- Acronym
- CRESPA
- Status last verified
- May 2019
- First submitted
- 30 Aug 2011
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Krabbe S, Renson T, Jans L, Elewaut D, Van den Bosch F, Carron P, Ostergaard M. Performance of an MRI scoring system for inflammation of joints and entheses in peripheral SpA: post-hoc analysis of the CRESPA trial. Rheumatology (Oxford). 2023 Jun 1;62(6):2130-2138. doi: 10.1093/rheumatology/keac567.
PubMed 36200875Carron P, De Craemer AS, Renson T, Colman R, Elewaut D, Van den Bosch F. TNFi-induced sustained clinical remission in peripheral spondyloarthritis patients cannot be maintained with a step-down strategy based on methotrexate. Rheumatology (Oxford). 2021 Oct 2;60(10):4880-4883. doi: 10.1093/rheumatology/keab056.
PubMed 33471112Carron P, Varkas G, Renson T, Colman R, Elewaut D, Van den Bosch F. High Rate of Drug-Free Remission After Induction Therapy With Golimumab in Early Peripheral Spondyloarthritis. Arthritis Rheumatol. 2018 Nov;70(11):1769-1777. doi: 10.1002/art.40573.
PubMed 29806090Carron P, Varkas G, Cypers H, Van Praet L, Elewaut D, Van den Bosch F; CRESPA investigator group. Anti-TNF-induced remission in very early peripheral spondyloarthritis: the CRESPA study. Ann Rheum Dis. 2017 Aug;76(8):1389-1395. doi: 10.1136/annrheumdis-2016-210775. Epub 2017 Feb 17.
PubMed 28213565
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria
- ClinicalTrials.gov ID
- NCT01426815
- Acronym / sponsor ID
- CRESPA / 2011/529
- Conditions
- Peripheral Spondylarthritis
- Keywords
- Peripheral spondylarthritis according to ASAS- criteria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Janssen Biologics BV
- Study start
- 13 Mar 2012 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 31 Aug 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.
In this Investigator Initiated study, the investigators want to explore the potential of an induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease stage (less than 3 months of symptom duration) of patients with predominant peripheral spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early ("immature") stage of the disease would result in a significant higher number of patients in clinical remission compared to placebo, and that - comparable to the early Rheumatoid Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to maintain this remission in a number of patients.
In this placebo-controlled, double blind, randomized study (with open-label phase, starting at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2 golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If patients are in 'clinical remission' (clinical remission is defined by the absence of arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In case of clinical relapse, patients will be treated with open-label golimumab 50 mg SC. Patients in sustained clinical remission will be observed to assess the possibility of maintaining drug-free remission. The study duration will be 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Golimumab 50mg (Simponi ®) | Experimental | Drug: Golimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- A subject will be eligible for study participation if all of the following criteria are met:
- Subject is ≥ 18 years of age
- Subjects must meet the new Assessment of SpondyloArthritis (ASAS) criteria for peripheral spondyloarthritis:
- o Subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis PLUS:
- At least 1 of the following Peripheral Spondyloarthritis (SpA) features:
Key exclusion criteria (17 listed)
- Medical history of inflammatory arthritis of a different etiology other than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, or any arthritis with onset prior to age 16 years such as Juvenile idiopathic arthritis (JIA)).
- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy.
- Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to the Baseline Visit.
- Infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline Visit.
- Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
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 |
|---|---|---|
| PlaceboThe prefilled syringe with placebo will be administrated subcutaneously every 4 weeks during a study period of 24 weeks. | Drug | Placebo |
| GolimumabThe prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks. | Drug | Golimumab 50mg (Simponi ®) |
Primary outcome
Clinical remission
Time frame: At 24 weeks
The primary endpoint of the study is the induction of clinical remission (complete resolution of synovitis/dactylitis/enthesitis which was present at baseline) and prevention of newly developing peripheral and/or axial spondylarthritis signs). The primary analysis will be a comparison at 24 weeks of the percentage of patients in clinical remission in the group treated with the Tumor Necrosis Factor (TNF)-blocking agent versus placebo.
6 secondary outcomes
The improvement in the tender and swollen joint count
Time frame: At week 24.
The improvement in dactylitis with obtaining a circumference measurement and clinical picture.
Time frame: At week 24.
The improvement in enthesitis, using the different scoring systems with inclusion of all relevant entheses.
Time frame: At 24 weeks.
The improvement in global measurements of disease activity.
Time frame: At 24 weeks.
The exploration of the utility of conventional ankylosing spondylitis measurements such as BASDAI, BASFI, BASMI
Time frame: At week 24.
The exploration of the safety of (Tumor Necrosis Factor)TNF-α blockade in patients with early peripheral spondyloarthritis.
Time frame: At 24 weeks.
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 29 May 2019.
- Derived from this study: PubMed 36200875Krabbe S, Renson T, Jans L, Elewaut D, Van den Bosch F, Carron P, Ostergaard M. Performance of an MRI scoring system for inflammation of joints and entheses in peripheral SpA: post-hoc analysis of the CRESPA trial. Rheumatology (Oxford). 2023 Jun 1;62(6):2130-2138. doi: 10.1093/rheumatology/keac567.
- Derived from this study: PubMed 33471112Carron P, De Craemer AS, Renson T, Colman R, Elewaut D, Van den Bosch F. TNFi-induced sustained clinical remission in peripheral spondyloarthritis patients cannot be maintained with a step-down strategy based on methotrexate. Rheumatology (Oxford). 2021 Oct 2;60(10):4880-4883. doi: 10.1093/rheumatology/keab056.
- Derived from this study: PubMed 29806090Carron P, Varkas G, Renson T, Colman R, Elewaut D, Van den Bosch F. High Rate of Drug-Free Remission After Induction Therapy With Golimumab in Early Peripheral Spondyloarthritis. Arthritis Rheumatol. 2018 Nov;70(11):1769-1777. doi: 10.1002/art.40573.
- Derived from this study: PubMed 28213565Carron P, Varkas G, Cypers H, Van Praet L, Elewaut D, Van den Bosch F; CRESPA investigator group. Anti-TNF-induced remission in very early peripheral spondyloarthritis: the CRESPA study. Ann Rheum Dis. 2017 Aug;76(8):1389-1395. doi: 10.1136/annrheumdis-2016-210775. Epub 2017 Feb 17.
- Related InfoLink provided by the sponsor.
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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.
Filip Vandenbosch, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Golimumab in people with Peripheral Spondylarthritis, run by University Hospital, Ghent at 1 site in Belgium.
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 25 inclusion and 17 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 29 May 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 Belgium. 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. Some participants in this study may receive a placebo. 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 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?
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?
Clinical remission (time frame: At 24 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 NCT01426815, 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 29 May 2019.