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Ankylosing SpondylitisASSIALNCT01856569

Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy

An observational study of Ankylosing Spondylitis, run by Pfizer at 18 sites in Italy.

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

Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
How many people
152 participants
Where
18 sitesItaly
Study dates
Jul 2013to Nov 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ankylosing spondylitis

Who may be able to join

  • retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement

Who cannot join

  • patients in other AS studies involved

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Italy18 sites

  • U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • Piazzale Spedali Civili

    Brescia, 125128

  • Policlinico Di Cagliari, Dipartimento Di Scienze Mediche

    Cagliari, 09100

  • Unita Operativa Semplice di Reumatologia

    Catania, CT, 95100

  • Arcispedale Sant'Anna

    Ferrara, Italy, 44100

  • Via Torregalli, 3

    Florence, 50143

  • Ospedale Ortopedico G. Pini

    Milan, 20122

  • Fondazione San Raffaele del Monte Tabor

    Milan, 20132

  • Policlinico Universitario, II Universita

    Naples, 80131

  • Policlinico Universitario

    Padova, 35128

  • Divisione di Reumatologia

    Palermo, 90134

  • Policlinico Universitario P. Giaconne

    Palermo, 90146

  • Azienda USL 4 di Prato

    Prato

  • Università Campus Bio-Medico di Roma- Policlinico Universitario Campus Bio-medico di Roma

    Roma, 00128

  • Policlinico Umberto I

    Roma

  • Ospedale Mauriziano Umberto I

    Torino, 10128

  • Policlinico Universitario

    Udine, 33100

  • Ospedale Borgo Trento - Clinica Reumatologica

    Verona, 37126

Other trials in Italy

About this study

Official title: Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy

Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.

Read the detailed description

retrospective and prospective 150

Being tested
no intervention
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • no interventionOther

    Also called adherence of therapy,switching,combo therapy

    in real life of drug,dosage,frequency and duration

Study groups in NCT01856569
Study groupRoleWhat they receive
observationalNot described
Receives: Other: no intervention

What is being measured

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

  1. Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18

    First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.

    Measured: Baseline up to Month 18

  2. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18

    BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.

    Measured: Baseline, Month 18

  3. Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity

    Low disease activity was defined as a BASDAI score of less than or equal to (<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.

    Measured: Month 12, 18

Secondary outcomes (3)

  1. Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18

    ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).

    Measured: Month 18

  2. C Reactive Protein Level at Baseline

    C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.

    Measured: Baseline

  3. Erythrocyte Sedimentation Rate at Baseline

    Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).

    Measured: Baseline

Timeline

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

  1. First posted17 May 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

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
Other
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856569
Sponsor's protocol ID
B1801362
Other IDs
B1801362
Acronym
ASSIAL
Status last verified
Jan 2017
First submitted
14 May 2013
Last updated
9 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by Pfizer at 18 sites in Italy.

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 1 inclusion and 1 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18 (time frame: Baseline up to Month 18). The study lists 3 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 NCT01856569.

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 9 Mar 2017.

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