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

NCT01856569 | Completed Results

• 1 other identifier: B1801362
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  Month 18

• C Reactive Protein Level at Baseline

  Baseline

• Erythrocyte Sedimentation Rate at Baseline

  Baseline

Study Arms (1)

observational

Other: no intervention

Interventions

no intervention OTHER

in real life of drug,dosage,frequency and duration

Also known as: adherence of therapy,switching,combo therapy

observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ankylosing spondylitis

You may qualify if:

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

You may not qualify if:

• patients in other AS studies involved

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Unita Operativa Semplice di Reumatologia

Catania, CT, 95100, Italy

Location

Arcispedale Sant'Anna

Ferrara, Italy, 44100, Italy

Location

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

Bologna, 40138, Italy

Location

Piazzale Spedali Civili

Brescia, 125128, Italy

Location

Policlinico Di Cagliari, Dipartimento Di Scienze Mediche

Cagliari, 09100, Italy

Location

Via Torregalli, 3

Florence, 50143, Italy

Location

Ospedale Ortopedico G. Pini

Milan, 20122, Italy

Location

Fondazione San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

Policlinico Universitario, II Universita

Napoli, 80131, Italy

Location

Policlinico Universitario

Padua, 35128, Italy

Location

Divisione di Reumatologia

Palermo, 90134, Italy

Location

Policlinico Universitario P. Giaconne

Palermo, 90146, Italy

Location

Azienda USL 4 di Prato

Prato, Italy

Location

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

Roma, 00128, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

Policlinico Universitario

Udine, 33100, Italy

Location

Ospedale Borgo Trento - Clinica Reumatologica

Verona, 37126, Italy

Location

Related Links

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

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Limitations and Caveats

Data for change from baseline in ASQoL score was not collected as per change in planned analyses.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

IT (18)