Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

NCT01273519 | Completed Results

• 1 other identifier: P12-585
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

Ankylosing; Rheumatoid; Antibodies; Arthritis; Pain; Antirheumatic Agents; Psoriatic; Spondylitis; Monoclonals

Outcome Measures

Primary Outcomes (9)

• Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12

  Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).

  Baseline, Months 3, 6, 9, 12

• Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12

  Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).

  Baseline, Months 3, 6, 9, 12

• Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12

  Participants measured their present pain intensity by specifying their level of pain in response to the question "How intensive is your pain at present?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.

  Baseline, Month 12

• Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12

  Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).

  Baseline, Months 3, 6, 9, 12

• Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12

  Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question "How intensive was your pain on average in the past 3 months?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.

  Baseline, Month 12

• Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12

  Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).

  Baseline, Month 12

• Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12

  Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.

  Baseline, Month 12

• Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12

  Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.

  Baseline, Month 12

• Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12

  Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.

  Baseline, Month 12

Secondary Outcomes (7)

• Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12

  Baseline, Months 3, 6, 9, 12

• Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12

  Baseline, Months 3, 6, 9, 12

• Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12

  Baseline, Months 3, 6, 9, 12

• Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12

  Baseline, Months 3, 6, 9, 12

• Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12

  Baseline, Months 3, 6, 9, 12

Study Arms (1)

RA, PsA, AS

Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic and medical practice specialized in rheumatology

You may qualify if:

• Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
• Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:
• unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
• unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis

You may not qualify if:

• Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
• Patients participating in another study program or clinical trial
• Patients who have been treated with Humira before

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Raffeiner GmbH: collaborator

Study Sites (15)

Site Reference ID/Investigator# 52144

Bludenz, 6700, Austria

Location

Site Reference ID/Investigator# 44915

Fürstenfeld, 8280, Austria

Location

Site Reference ID/Investigator# 44910

Gloggnitz, A-2640, Austria

Location

Site Reference ID/Investigator# 44914

Graz, A-8020, Austria

Location

Site Reference ID/Investigator# 52143

Innsbruck, 6020, Austria

Location

Site Reference ID/Investigator# 44916

Klagenfurt, A-9020, Austria

Location

Site Reference ID/Investigator# 44911

Linz, 4030, Austria

Location

Site Reference ID/Investigator# 44912

Linz, A-4020, Austria

Location

Site Reference ID/Investigator# 44913

Linz, A-4020, Austria

Location

Site Reference ID/Investigator# 44906

Neudorf, A-2351, Austria

Location

Site Reference ID/Investigator# 44909

Sankt Pölten, 3100, Austria

Location

Site Reference ID/Investigator# 52145

Spitz, 3620, Austria

Location

Site Reference ID/Investigator# 44908

Stockerau, 2000, Austria

Location

Site Reference ID/Investigator# 67062

Vienna, 1040, Austria

Location

Site Reference ID/Investigator# 57304

Vöcklabruck, A-4840, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Arthritis; Pain; Spondylitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Infections

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Astrid Dworan-Timler, MD

  AbbVie Austria

  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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 26, 2014
• Results First Posted: February 24, 2014

Record last verified: 2014-02

Locations

AU (15)