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

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Other: no intervention

Detailed Description

retrospective and prospective 150

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi
  • Brescia, Italy, 125128
    • Piazzale Spedali Civili
  • Cagliari, Italy, 09100
    • Policlinico Di Cagliari, Dipartimento Di Scienze Mediche
  • Ferrara, Italy, 44100
    • Arcispedale Sant'Anna
  • Firenze, Italy, 50143
    • Via Torregalli, 3
  • Milano, Italy, 20132
    • Fondazione San Raffaele del Monte Tabor
  • Milano, Italy, 20122
    • Ospedale Ortopedico G. Pini
  • Napoli, Italy, 80131
    • Policlinico Universitario, II Universita
  • Padova, Italy, 35128
    • Policlinico Universitario
  • Palermo, Italy, 90134
    • Divisione di Reumatologia
  • Palermo, Italy, 90146
    • Policlinico Universitario P. Giaconne
  • Prato, Italy
    • Azienda USL 4 di Prato
  • Roma, Italy
    • Policlinico Umberto I
  • Roma, Italy, 00128
    • Università Campus Bio-Medico di Roma- Policlinico Universitario Campus Bio-medico di Roma
  • Torino, Italy, 10128
    • Ospedale Mauriziano Umberto I
  • Udine, Italy, 33100
    • Policlinico Universitario
  • Verona, Italy, 37126
    • Ospedale Borgo Trento - Clinica Reumatologica
  • CT
    • Catania, CT, Italy, 95100
      • Unita Operativa Semplice di Reumatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ankylosing spondylitis

Description

Inclusion Criteria:

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

Exclusion Criteria:

patients in other AS studies involved

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observational	Other: no intervention; in real life of drug,dosage,frequency and duration; Other Names: adherence of therapy,switching,combo therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Month 18
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.	Baseline, Month 18
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.	Month 12, 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 18
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.	Baseline
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).	Baseline

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: B1801362