Axial and Peripheral SpondyloarthritisPhase 3SCINTRANCT01590966

Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis

A Phase 3 study testing administration of Cimzia® and Immunoscintigraphy with radiolabeled Cimzia®. in people with Axial and Peripheral Spondyloarthritis and Rheumatoid Arthritis, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Axial and Peripheral Spondyloarthritis, Rheumatoid Arthritis
What is being tested?: administration of Cimzia® and Immunoscintigraphy with radiolabeled Cimzia®.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteBelgium
Study dates: 18 Oct 2012to 20 Aug 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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

INCLUSION CRITERIA FOR RHEUMATOID ARTHRITIS PATIENTS (5 PATIENTS)

Age between 18 and 70 years-old with documented diagnosis (clinical evaluation, x-ray hands and feet minimum 2 months before inclusion) of rheumatoid arthritis minimum 3 months and maximum 15 years according to ACR criteria 1987. At least 8 tender and 8 swollen joints with inadequate response to at least 2 disease-modifying antirheumatic drugs (DMARDs) of which one is Methotrexate (MTX). Methotrexate must have been administered at least 3 months before baseline and doses and route must be stable for at least 2 months before baseline. Minimum dosage of MTX is 10 mg weekly and maximum dosage is 25 mg weekly. HAQ (Health assessment Score) score at least 25 at baseline and DAS 28(Disease Activity Score) > 3.7 at baseline.
All patients are biological naïve patients.
Negative for Tuberculosis (TB) (also in history) and negative screening for TB (Mantoux test / x-ray thorax)
Female patients must be post-menopausal for at least 1 year or must underwent surgery so that they cannot become pregnant. Women of child bearing potential must use adequate contraception throughout the study and 12 weeks after the last dose of certolizumab pegol.
Patient need to understand the study and sign an informed consent form approved by the ethics committee before participation in this study.

INCLUSION CRITERIA FOR PATIENTS WITH AXIAL SPONDYLARTHROPATY (15 PATIENTS)

Age between 18 and 70-years old with presence of a documented diagnosis of spondylarthropathy according to current ASAS criteria valid for all of the 3 sub-groups (early axial, early peripheral and established axial)
10 patients with axial SpA must fulfill current ASAS criteria for AxSpA and 5 of them need to fulfill the current modified New York criteria:
Chronic low back pain > 3 months and onset of age < 45 years
Active inflammatory injury on sacro-iliac joints on MRI. Active inflammatory injuries are defined as oedema of bone in or around the sacro-iliac joints, compatible with active injuries seen on axial SpA with STIR (short tau inversion recovery) MRI
Inadequate response on previously, optimal use of min 2 Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) in a anti-inflammatory dosage during 3 months or a medical contra-indication for use of NSAIDs
BASDAI score ≥ 4
5 patients with peripheral SpA must have presence of clinical peripheral arthritis or enthesitis or dactylitis with active disease activity, even under a stable dose of sulfasalazine during 3 months AND presence of one of the following:
Psoriasis of skin
Inflammatory bowel disease
Positive HLA B27
sacro-iliitis on image (X-ray or MRI of the sacro-iliac joints)
all patients are anti-TNF naive
No active tuberculosis (in medical history as current) and negative screening for latent TB (Mantoux test and X-ray thorax).
Female patients must be post-menopausal for at least 1 year or must underwent surgery so that they cannot become pregnant. Women of child bearing potential must use adequate contraception throughout the study and 12 weeks after the last dose of certolizumab pegol.
Patient need to understand the study and sign an informed consent form approved by the ethics committee before participation in this study.

EXCLUSION CRITERIA FOR RHEUMATOID ARTHRITIS AND SPONDYLOARTHROPATHY PATIENTS

Patients cannot have treatment with experimental biological and non-biological therapy in the last 3 months or 5-times the half-live prior to baseline visit
Patients who had previously treatment with anti-TNF
Patients who had previously treatment with rituximab and/or abatacept
Known hypersensitivity to certolizumab pegol (Cimzia®) or one of it compounds
Current or recent medical history of progressive uncontrolled renal, hepatic, hematological, gastro-intestinal, endocrine, pulmonary, cardial, neurological or cerebral diseases.
Severe or life threatening infections in the last 6 months; signs of current or recent infection
Active or latent tuberculosis: in case one or more of the 3 criteria are positive: medical history of TB, recent (< 6 months) X-ray chest or recent positive PPD skin
Known history or current viral hepatitis B of hepatitis C
Known HIV infection
Malignancy or history of a malignancy
History of lymph-proliferative disease or signs/symptoms suggestive fort his disease.
Moderate to severe hart failure (NYHA-class III/IV)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University Hospital
Ghent, 9000

Other trials in Belgium

About this study

In this open-label monocentric explorative pilot trial the objective is to show the biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to show the TNFα triggered inflammation process in the inflamed joints, especially in patients who have very early joint damage where currently other imaging methods such as X-rays are not sensitive enough for detection.

Conditions: Axial and Peripheral Spondyloarthritis, Rheumatoid Arthritis
Being tested: administration of Cimzia®, Immunoscintigraphy with radiolabeled Cimzia®.
Keywords: spondyloarthritis, Rheumatoid arthritis
Medical subject headings: Arthritis, Rheumatoid, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

administration of Cimzia®Drug
Patients will be treated with prefilled syringes containing each 200 mg/ml Cimzia® every 2 weeks which will be administered subcutaneously (The first 3 injections, a dosage of 400mg Cimzia® subcutaneously will be administered).
Immunoscintigraphy with radiolabeled Cimzia®.Drug
All 20 patients will undergo an immunoscintigraphy with radiolabeled Cimzia®. Certolizumab pegol (Cimzia®) is an engineered humanized monoclonal antibody Fab' fragment with specificity for human TNF-α, manufactured in E. coli. The antibody fragment is subsequently purified and conjugated with high molecular weight polyethylene glycol (PEG) (40kDa). Lyophilized Cimzia® will be conjugated with S-HYNIC (a bifunctional chelator). The conjugate will be radiolabeled with Tc-99m by adding 0.1 mg Tricine, 0.01 mg SnSO4 and 750 MBq Tc-99m pertechnetate. A dose of 750 MBq Tc-99m Cimzia® will be injected intravenously.

Study groups in NCT01590966
Study group	Role	What they receive
Patients with an active inflammatory joint disease	Experimental	In total there will be 20 patients included: 5 patients with active rheumatoid arthritis, 5 patients with active early axial spondyloarthritis, 5 patients with active early peripheral spondyloarthritis and 5 patients with active ankylosing spondylitis. Receives: Drug: administration of Cimzia®; Drug: Immunoscintigraphy with radiolabeled Cimzia®.

What is being measured

The primary outcome is the main question the study is designed to answer.

Biodistribution of Cimzia® after administration of radiolabeled Cimzia®.
After performing the immunoscintigraphy there will be evaluation of the correlation between visualised joint inflammation on the one hand seen by clinical examination , on MRI and on ultrasound and on the other hand seen on the immunoscintigraphy.
Measured: at baseline
Percentage of remission in patients, treated with Cimzia® after 14 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 14 weeks of administration.
Percentage of remission in patients, treated with Cimzia® after 26 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 26 weeks of administration.
Percentage of remission in patients, treated with Cimzia® after 38 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 38 weeks of administration.
Percentage of remission in patients, treated with Cimzia® after 50 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 50 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 14 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 14 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 26 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 26 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 38 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 38 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 50 weeks.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Measured: After 50 weeks of administration.

Secondary outcomes (3)

Improvement in the tender and swollen joint count.
A secondary endpoint will be the changes in the tender and swollen joint count (76/78 joint count) at week 26 in comparison with baseline.
Measured: 26 weeks after baseline.
Improvement in enthesitis
This will be done by using the different scoring systems with inclusion of all relevant entheses.
Measured: 26 weeks after baseline.
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, BASDAI and DAS28.
Measured: 26 weeks after baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 201220 Aug 2019

First posted3 May 2012 (estimated)
Study start18 Oct 2012
Primary completion26 Mar 2019
Study completion20 Aug 2019

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 Axial and Peripheral SpondyloarthritisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01590966
Sponsor's protocol ID: 2012/279
Other IDs: 2009-017998-37, 2009
Acronym: SCINTRA
Status last verified: Dec 2014
First submitted: 30 Apr 2012
Last updated: 26 Aug 2019
Results posted: No
Data monitoring committee: No

Publications

Carron P, Lambert B, Van Praet L, De Vos F, Varkas G, Jans L, Elewaut D, Van den Bosch F. Scintigraphic detection of TNF-driven inflammation by radiolabelled certolizumab pegol in patients with rheumatoid arthritis and spondyloarthritis. RMD Open. 2016 Jun 24;2(1):e000265. doi: 10.1136/rmdopen-2016-000265. eCollection 2016.
PubMed 27403334

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis
ClinicalTrials.gov ID: NCT01590966
Acronym / sponsor ID: SCINTRA / 2012/279
Conditions: Axial and Peripheral Spondyloarthritis, Rheumatoid Arthritis
Keywords: spondyloarthritis, Rheumatoid arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: UCB Pharma SA
Study start: 18 Oct 2012 (actual)
Primary completion: 26 Mar 2019 (actual)
Study completion: 20 Aug 2019 (actual)
First posted: 3 May 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with an active inflammatory joint disease	Experimental	Drug: administration of Cimzia®, Drug: Immunoscintigraphy with radiolabeled Cimzia®.In total there will be 20 patients included: 5 patients with active rheumatoid arthritis, 5 patients with active early axial spondyloarthritis, 5 patients with active early peripheral spondyloarthritis and 5 patients with active ankylosing spondylitis.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
administration of Cimzia®Patients will be treated with prefilled syringes containing each 200 mg/ml Cimzia® every 2 weeks which will be administered subcutaneously (The first 3 injections, a dosage of 400mg Cimzia® subcutaneously will be administered).	Drug	Patients with an active inflammatory joint disease
Immunoscintigraphy with radiolabeled Cimzia®.All 20 patients will undergo an immunoscintigraphy with radiolabeled Cimzia®. Certolizumab pegol (Cimzia®) is an engineered humanized monoclonal antibody Fab' fragment with specificity for human TNF-α, manufactured in E. coli. The antibody fragment is subsequently purified and conjugated with high molecular weight polyethylene glycol (PEG) (40kDa). Lyophilized Cimzia® will be conjugated with S-HYNIC (a bifunctional chelator). The conjugate will be radiolabeled with Tc-99m by adding 0.1 mg Tricine, 0.01 mg SnSO4 and 750 MBq Tc-99m pertechnetate. A dose of 750 MBq Tc-99m Cimzia® will be injected intravenously.	Drug	Patients with an active inflammatory joint disease

Primary outcome

Biodistribution of Cimzia® after administration of radiolabeled Cimzia®.
Time frame: at baseline
After performing the immunoscintigraphy there will be evaluation of the correlation between visualised joint inflammation on the one hand seen by clinical examination , on MRI and on ultrasound and on the other hand seen on the immunoscintigraphy.
Percentage of remission in patients, treated with Cimzia® after 14 weeks.
Time frame: After 14 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Percentage of remission in patients, treated with Cimzia® after 26 weeks.
Time frame: After 26 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Percentage of remission in patients, treated with Cimzia® after 38 weeks.
Time frame: After 38 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Percentage of remission in patients, treated with Cimzia® after 50 weeks.
Time frame: After 50 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Duration of remission in patients, treated with Cimzia® after 14 weeks.
Time frame: After 14 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Duration of remission in patients, treated with Cimzia® after 26 weeks.
Time frame: After 26 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Duration of remission in patients, treated with Cimzia® after 38 weeks.
Time frame: After 38 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.
Duration of remission in patients, treated with Cimzia® after 50 weeks.
Time frame: After 50 weeks of administration.
All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.

3 secondary outcomes

Improvement in the tender and swollen joint count.
Time frame: 26 weeks after baseline.
Improvement in enthesitis
Time frame: 26 weeks after baseline.
Improvement in global measurements of disease activity.
Time frame: 26 weeks after baseline.

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 26 Aug 2019.
Derived from this study: PubMed 27403334Carron P, Lambert B, Van Praet L, De Vos F, Varkas G, Jans L, Elewaut D, Van den Bosch F. Scintigraphic detection of TNF-driven inflammation by radiolabelled certolizumab pegol in patients with rheumatoid arthritis and spondyloarthritis. RMD Open. 2016 Jun 24;2(1):e000265. doi: 10.1136/rmdopen-2016-000265. eCollection 2016.
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 Van den Bosch, 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?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 26 Aug 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. 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?

Biodistribution of Cimzia® after administration of radiolabeled Cimzia®. (time frame: at baseline). The study lists 9 primary outcomes in all. 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 NCT01590966, 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 26 Aug 2019.