A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New to Conventional, Targeted and Biological DMARDs (SIRENA)

September 28, 2021 updated by: Janssen-Cilag S.p.A.

A Prospective, Observational Study, in Patients With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) According to ASAS Criteria, naïve to Conventional (cDMARDs), Targeted (tsDMARDs) and Biological DMARDs (bDMARDs) - SIRENA Study (Spondyloarthritis Italian Registry: Evidence From a National Pathway)

The purpose of this Italian multicenter study is to collect prospective clinical data in participants with first diagnosis or confirmation diagnosis of Spondyloarthritis (SpA), according to Assessment of Spondyloarthritis classification (ASAS) criteria, in order to describe SpA characteristics and pattern of clinical presentation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali Civili Brescia
      • Campobasso, Italy, 86100
        • Ospedale 'Antonio Cardarelli' di Campobasso - Azienda Sanitaria Regionale del Molise
      • Catania, Italy, 95122
        • P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Mater Domini
      • Catanzaro, Italy, 88100
        • AO di Catanzaro 'Pugliese Ciaccio'
      • Foggia, Italy, 71100
        • Ospedali Riuniti Foggia
      • Genova, Italy, 16100
        • Ospedale La Colletta-Arenzano ASL3 Genovese
      • Milan, Italy, 20132
        • Ospedale San Raffaele, IRCCS
      • Milano, Italy, 20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Napoli, Italy, 80130
        • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
      • Padova, Italy, 35128
        • Azienda Ospedaliera Di Padova
      • Padova, Italy, 35127
        • P.O. 'Sant'Antonio'
      • Palermo, Italy, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Perugia, Italy, 6122
        • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
      • Pescara, Italy, 65100
        • Presidio Ospedaliero Pescara
      • Potenza, Italy, 85100
        • Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
      • Roma, Italy, 00133
        • Policlinico Tor Vergata
      • Rozzano (MI), Italy, 20089
        • Humanitas Hospital
      • San Cesareo Di Lecce, Italy, 73016
        • Operative Unit of Rheumathology, Presidio Ospedaliero Vito Fazzi - Stabilimento Osp. A. Galateo
      • Scicli (Ragusa), Italy, 97018
        • Ospedale Busacca - Azienda Provinciale Sanitaria di Ragusa
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
      • Torrette - Ancona, Italy, 60126
        • A.O. Universitaria Ospedali Riuniti di Ancona
      • Udine, Italy, 33100
        • ASUI Santa Maria della Misericordia di Udine
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population will include outpatients with first diagnosis or confirmed diagnosis of Spondyloarthritis (SpA) and naïve to conventional, targeted or biological Disease modifying anti-rheumatic drugs (DMARDs) prescribed for SpA.

Description

Inclusion Criteria:

  • Participants must have a first or confirmed diagnosis of Spondyloarthritis (SpA) according to Assessment of Spondyloarthritis classification (ASAS) criteria
  • Participants must be naïve to conventional, targeted and biological Disease modifying anti-rheumatic drugs (DMARDs) treatment
  • Participants must understand the purpose of the study
  • Participants must sign a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

  • Participants who already started conventional, targeted and biological DMARDs treatment for SpA
  • Participants who participate to an investigational study in the last 30 days
  • Participants unwilling or unable to participate in long-term, 24 months, data collection
  • Participants unwilling or unable to fill in the Participant-reported outcome (PRO) foreseen by the protocol
  • Participants unwilling or unable to sign the informed consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
SpA with DMARDs
Participants with first diagnosis or confirmed diagnosis of Spondyloarthritis (SpA) and naïve to conventional, targeted or biological Disease modifying anti-rheumatic drugs (DMARDs) will be observed in order to describe SpA characteristics and pattern of clinical presentation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic Delay
Time Frame: Baseline (Month 0)
Time of diagnostic delay, defined as the time in months from first symptoms to diagnosis, and reasons for this delay.
Baseline (Month 0)
Prevalence of Axial Versus Peripheral Manifestations According to Assessment of Spondyloarthritis Classification (ASAS) Criteria
Time Frame: Up to visit 5 (Approximately 24 months)
The ASAS criteria distinguish axial from peripheral SpA. ASAS criteria for axial SpA: chronic back pain (>=3 months) with onset at age <45 years, and include imaging and clinical arm. Imaging criteria: must have sacroiliitis visible on either pelvic radiograph (representing the Ankylosing Spondylitis subgroup) or active inflammation detected by Magnetic Resonance Imagining (MRI) of the sacroiliac joints, and at least one other feature of SpA. Clinical criteria: should be Human Leukocyte Antigen (HLA) B27 positive and have at least two other SpA associated features. ASAS criteria for peripheral manifestations: must have arthritis, dactylitis or enthesitis in combination with either at least one of psoriasis, inflammatory bowel disease, uveitis, preceding genitourinary or gastro intestinal infection, HLA B27 positivity or sacroiliitis, or with two or more of arthritis, dactylitis, enthesitis, inflammatory back pain (at any time in the participant's history) or a family history of SpA.
Up to visit 5 (Approximately 24 months)
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by ASDAS Score
Time Frame: Up to visit 5 (Approximately 24 months)
The ASDAS is composite score based on the calculation of 5 disease activities: 4 are participant's reported outcomes (back pain, duration of morning stiffness, participant global and peripheral pain/swelling) and one serologic inflammation marker (C-reactive protein [CRP]). The score is the sum of the 5 items with different specified weights, with a minimum of 0 and no upper limit. Thus this index can reflect both long term disease activity and acute phase status. There are 2 cut-offs in score to show: a) the 4 states of disease activity: inactive disease (less than [<] 1.3), moderate disease activity (1.3-2.1), high disease activity (2.1-3.5) and very high disease activity (greater than [>] 3.5). b) effectiveness of the treatment, two validated cut-offs were developed: a change of 1.1-2.0 (clinically important improvement) and a change >2.0 (major improvement).
Up to visit 5 (Approximately 24 months)
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by BASMI Score
Time Frame: Up to visit 5 (Approximately 24 months)
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an index for measuring the mobility of the axial skeleton in participant affected by ankylosing spondylitis (AS). This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall distance, lumbar flexion, intermalleoar distance and cervical rotation. Individual scores are averaged to give a final score between 0 and 10. A higher BASMI10 score reflects more severe spinal mobility limitation.
Up to visit 5 (Approximately 24 months)
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by DAS28 Score
Time Frame: Up to visit 5 (Approximately 24 month)
The Disease Activity and functional status assessment (DAS) 28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0 = no disease activity to 100 = maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 less than or equal to (<=) 3.2 or a change from Baseline less than (<) -1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to <= 5.1 or a change from Baseline < -0.6 to greater than or equal to (>=) -1.2.
Up to visit 5 (Approximately 24 month)
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by Disease Activity Index for PsA (DAPSA) Score
Time Frame: Up to visit 5 (Approximately 24 months)
The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on visual analog scale (VAS) (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Joints assessed include the distal interphalangeal (DIP), proximal interphalangeal (PIP), and metacarpophalangeal (MCP) joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and PIP joints of the feet. CRP level in milligrams per deciliters (mg/dL). Cutoff values for low and high disease activity are <= 18.5 and >= 45.1 points, 25 respectively, and for remission is <= 3.3 points.
Up to visit 5 (Approximately 24 months)
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by MDA
Time Frame: Up to visit 5 (Approximately 24 months)
Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the participant and physician. The goal of the development of this instrument is to "treat to target" to achieve disease remission or low disease activity state. For a participant to achieve MDA, 5 of the following 7 criteria must be met: Tender joint count =<1; Swollen joint count =<1; Psoriasis Area and Severity Index (PASI) =<1 or Body surface area (BSA) =<3; Participant pain VAS =<15; Participant global activity VAS =<20; HAQ =<0.5; Tender enthesial points =<1.
Up to visit 5 (Approximately 24 months)
Drug Retention for cDMARDs, tDMARDs and bDMARDs
Time Frame: Up to visit 5 (Approximately 24 months)
Drug Retention is defined as the time in months in which participants maintain the same therapy.
Up to visit 5 (Approximately 24 months)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to visit 5 (Approximately 24 months)
An adverse event is any untoward medical occurrence in a clinical study that does not necessarily have a causal relationship with the investigational drug under study.
Up to visit 5 (Approximately 24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP)
Time Frame: Up to visit 5 (Approximately 24 month)
The ASDAS is an index for measuring disease activity in participant affected by ankylosing spondylitis. The ASDAS-CRP is derived from back pain, duration of morning stiffness, general well being, C-reactive protein (CRP) and peripheral joint pain/swelling. Total score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of CRP. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).
Up to visit 5 (Approximately 24 month)
Bath Ankylosing Spondylitis Metrology Index (BASMI) 10
Time Frame: Up to visit 5 (Approximately 24 month)
The BASMI is an index for measuring the mobility of the axial skeleton in participant affected by ankylosing spondylitis. This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall distance, lumbar flexion, intermalleoar distance and cervical rotation. Individual scores are averaged to give a final score between 0 and 10. A higher BASMI10 score reflects more severe spinal mobility limitation.
Up to visit 5 (Approximately 24 month)
Disease Activity Score (DAS) 28
Time Frame: Up to visit 5 (Approximately 24 month)
The DAS 28 is a composite score derived from the following 4 measures. The index considers four parameters to obtain the total score: Count the number of swollen joints (out of the 28); Count the number of tender joints (out of the 28); C-reactive protein (CRP) expressed in milligram per milliLitre (mg/mL); Participant's Global Assessment of disease activity.
Up to visit 5 (Approximately 24 month)
Disease Activity Index for Psoriatic Arthritis (DAPSA)
Time Frame: Up to visit 5 (Approximately 24 month)
The DAPSA is a score used to measure disease activity in participant affected by psoriatic arthritis. It comprises: 68 tender and 66 swollen joints count; Participant global assessment of health; Participant pain Visual analogue scale (VAS); C-reactive protein level (milligram per deciLiter [mg/dl]).
Up to visit 5 (Approximately 24 month)
Minimal Disease Activity (MDA)
Time Frame: Up to visit 5 (Approximately 24 month)
The MDA is a state of disease activity deemed a useful target of treatment by both the participant and physician. For a participant to achieve MDA, 5 of the following 7 criteria must be met: Tender joint count less than or equal to (<=) 1; Swollen joint count <= 1; PASI <= 1 or BSA <= 3; Participant pain VAS <= 15; Participant global activity VAS <= 20; Health Assessment Questionnaire (HAQ) <= 0.5; Tender enthesial points <= 1.
Up to visit 5 (Approximately 24 month)
Body Surface Area (BSA)
Time Frame: Up to visit 5 (Approximately 24 month)
The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" which equates to approximately 1 % of total body surface area. The disease severity will be classified using the following categories: mild (BSA less than [<] 3 %), moderate (BSA from 3% to 10%), and severe (BSA more than [>] 10 %).
Up to visit 5 (Approximately 24 month)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Up to visit 5 (Approximately 24 month)
The BASFI is used to define and monitor physical functioning in participants with ankylosing spondylitis. BASFI is composed by 10 items. Score range is 0-10, with 0 (easy), reflecting no functional impairments, and 10 (impossible), reflecting maximal impairment.
Up to visit 5 (Approximately 24 month)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Up to visit 5 (Approximately 24 month)
The BASDAI is used to measure participant reported disease activity in participants with ankylosing spondylitis. A numeric response scale (0-10) with "none" and "very severe" is used to answer. The final score ranges from 0 (no disease activity) to 10 (maximal disease activity). A cut off of 4 is used to define active disease.
Up to visit 5 (Approximately 24 month)
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Up to visit 5 (Approximately 24 month)
The HAQ-DI is used to assess the physical functioning of the participant.The participant is required to indicate the degree of difficulty they have experienced, in each 8 items of the questionnaire, in the past week, in a 4 point scale. The responses in each functional area are: 0 = able to do with no difficulty; 1 = able to do with some difficulty; 2 = able to do with much difficulty; and 3 = unable to do. The 10 individual subscale scores are averaged to give a summary score. The range of the final calculates summary score is 0-3 where lower scores are indicative of better functioning and higher score reflects worse function. HAQ-DI scores of 0 to 1 generally represent mild to moderate functional difficulty, 1 to 2 represent moderate to severe functional difficulty, and 2 to 3 indicate severe to very severe limitations of physical function or disability.
Up to visit 5 (Approximately 24 month)
Work Productivity and Activity Impairment Questionnaire (WPAI-SHP)
Time Frame: Up to visit 5 (Approximately 24 month)
The WPAI is a validated, self administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI-SHP outcomes are expressed as impairment percentages; with higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
Up to visit 5 (Approximately 24 month)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With 66/68 Swollen/Tender Joints Count
Time Frame: Up to 5 visits (approximately 24 months)
Participant's swollen and tender joints 66/68 will be evaluated at each visit.
Up to 5 visits (approximately 24 months)
Physician Global Assessment of Participant (PhGA) Joints and Skin
Time Frame: Up to 5 visits (approximately 24 months)
The PhGA, joint and skin, will be manually filled in by physician and will be documented using a VAS scale. PhGA VAS for pain ranges from "Quite" (0 millimeter [mm]) to "Very Severe" (100 mm); VAS for joint ranges from "No Inflammation" (0 mm) to "Very Severe" (100 mm); VAS for skin ranges from "Clear" (0 mm) to "Very Severe" (100 mm).
Up to 5 visits (approximately 24 months)
Number of Participants With Enthesitis
Time Frame: Up to 5 visits (approximately 24 months)
The Maastricht Ankylosing Spondylitis Entheses Score (MASES) is a feasible index using to investigate the enthesitis. 13 specific and sensitive sites were examined and a dichotomous 0/1 score is used to value the grading of tenderness.
Up to 5 visits (approximately 24 months)
Number of Participants With Nail Lesions
Time Frame: Up to 5 visits (approximately 24 months)
Number of participants with count of nail lesions will be presented.
Up to 5 visits (approximately 24 months)
Number of Participants With Dactylitis
Time Frame: Up to 5 visits (approximately 24 months)
The total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.
Up to 5 visits (approximately 24 months)
Number of Participants With Fibromyalgia
Time Frame: Up to 5 visits (approximately 24 months)
Fibromyalgia is evaluated by American College of Rheumatology (ACR) 2010 criteria.
Up to 5 visits (approximately 24 months)
Number of Participants With Pain by Visual Analog Scale (VAS)
Time Frame: Up to 5 visits (approximately 24 months)
The pain VAS is a self-administered assessment used to measure the average pain during the past week. The score ranges between 0 "No pain" to 0 "The Worst Possible Pain".
Up to 5 visits (approximately 24 months)
Number of Participants With Sleep Quality by VAS
Time Frame: Up to 5 visits (approximately 24 months)
The Sleep Quality VAS questionnaire provides a measurement of quality of sleep experienced by the participant. This subjective method attempts to measure qualitative aspects of sleep and is easily administered. The score ranges from between 0 "Very Good" to 100 "Very Bad".
Up to 5 visits (approximately 24 months)
Participant's Global Assessment (PtGA) by VAS
Time Frame: Up to 5 visits (approximately 24 months)
The PtGA by VAS measuring the overall way the disease affects the participants at a point in time. The score will be recorded as a single vertical mark on a 100 millimeter (mm) visual analogic scale (VAS), with 0 representing the lowest level of disease activity and 100 representing the highest.
Up to 5 visits (approximately 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108297
  • CNTO1275PSA4006 (Other Identifier: Janssen-Cilag S.p.A., Italy)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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