Trial record 3 of 230 for:    Ankylosing Spondylitis

Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01474876
First received: November 16, 2011
Last updated: June 2, 2014
Last verified: May 2014
  Purpose

There is a need to evaluate the current diagnostic and treatment practices in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries, with special focus on the use of conventional disease modifying antirheumatic drugs (DMARDs) and biologic agents. Further, it is necessary to establish the long-term clinical outcomes of adalimumab therapy in routine clinical practice, in particular its sustained effectiveness, impact on extra-articular manifestations (EAMs), co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) and work productivity.

Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in Ankylosing Spondylitis (AS), is not yet widely used in routine clinical practice, and there is a lack of clinical data in Ankylosing Spondylitis (AS) (and Psoriatic Arthritis (PsA)) patients on adalimumab therapy, employing Ankylosing Spondylitis Disease Activity Score (ASDAS) as an outcome measure, particularly in comparison with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. Ankylosing Spondylitis Disease Activity Score (ASDAS) score will be calculated by the sponsor based on the data recorded otherwise during this Postmarketing observational study (PMOS).


Condition
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) score [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Primary endpoint is the percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined by at least 50% from baseline in case of axial symptoms.

  • Disease Activity Score/28 joints (DAS28) [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Primary endpoint is the percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined as a decrease by at least 1.2 from baseline in case of peripheral symptoms.

  • Ankylosing Spondylitis Disease Score (ASDAS) score [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Co-primary endpoint is the percentage of patients in remission at the end of the observational period of 12 months. Remission is defined as a score of < 1.3 in case of axial symptoms (which corresponds to Assessment in Ankylosing Spondylitis ASAS partial remission PR criterion).


Secondary Outcome Measures:
  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (in case of axial symptoms) and/or Disease Activity Score/28 joints (DAS28) (in case of peripheral symptoms) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Correlation between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) throughout the observational period of 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Predictors of maintained treatment response and/or remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) score (in case of peripheral symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) score (in case of axial symptoms) from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Change in the frequency of extra-articular manifestations (EAMs) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Duration of treatment with adalimumab [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Percentage of patients whose co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) could be stopped from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Changes in individual components of Work Productivity and Activity Impairment Specific Health Problem Questionnaire [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis) - (% Presenteeism, % Absenteeism, % Total work productivity impairment, % Total activity impairment) from baseline to 12 months

  • Change in the percentage of patients who have paid work from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with AS (Ankylosing Spondylitis)

  • Change in Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (in case of axial symptoms) and/or Disease Activity Score/ 28 joints (DAS28) (in case of peripheral symptoms) from study baseline to 12 months, [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with PsA (Psoriatic Arthritis)

  • Correlation between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) throughout the observational period of 12 months, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patients with PsA (Psoriatic Arthritis)

  • Predictors of maintained treatment response and/or remission, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patients with PsA (Psoriatic Arthritis)

  • Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score (in case of peripheral symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) score (in case of axial symptoms) from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with PsA (Psoriatic Arthritis)

  • Changes in individual components of Work Productivity and Activity Impairment-Specific Health Problem Questionnaire score (% Presenteeism, % Absenteeism, % Total work productivity impairment, % Total activity impairment) from baseline to 12 months [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
    Patients with PsA (Psoriatic Arthritis)


Enrollment: 566
Study Start Date: November 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ankylosing Spondylitis
Psoriatic Arthritis

Detailed Description:

This Postmarketing observational study (PMOS) will be conducted in a prospective, single-arm, multicenter, multi-country format.

According to the requirements for non-interventional or observational trials, no additional diagnostic or monitoring procedures will be applied to the patients included in the trial other than those which would ordinarily be applied in the course of the particular therapeutic strategy. Only data which are part of routine will be collected.

As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each patient.

Failure to observe these usual practice intervals of patient visits will not constitute a breach or violation of the protocol.

To optimize data collection, five (5) patient visits are indicated within the 12-month observational period:

  • Visit 0 (V0): Baseline
  • Visit 1 (V1): Follow-up at 3 months
  • Visit 2 (V2): Follow-up at 6 months
  • Visit 3 (V3): Follow-up at 9 months
  • Visit 4 (V4): Follow-up at 12 months (Study End). A patient may withdraw from this Postmarketing observational study ( PMOS) at any time without prejudice. If the physician, for any reason, decides it is in the best interest of the patient to permanently discontinue adalimumab, treatment should be stopped. The reason should be documented in the Case report form (CRF). The next routine follow-up visit will be the termination visit for the patient.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study is a post-marketing observational study (PMOS) where adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. Study population will consist of adult aged (>18 years) with Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) that can be administered adalimumab as per locally approved Summary of Product Characteristics (SmPC) and reimbursement criteria.

Criteria

Inclusion Criteria:

Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:

  1. Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).
  2. Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines.
  3. Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment.
  4. Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines.
  5. Are willing to provide Authorization to the investigator to use and/or disclose personal and/or health data, or to provide Informed Consent if requested by the Local Regulations, before entry into the study.

Exclusion Criteria:

Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):

1. Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474876

  Show 69 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Marta Gunjaca, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01474876     History of Changes
Other Study ID Numbers: P12-768
Study First Received: November 16, 2011
Last Updated: June 2, 2014
Health Authority: Latvia: Institutional Review Board
Romania: Ethics Committee
Estonia: Research Ethics Committee
Ukraine: Ethics Committee
Slovak Republic: Ethics Committee
Hungary: Institutional Ethics Committee
Czech Republic: Ethics Committee
Poland: Ethics Committee

Keywords provided by AbbVie:
Post-marketing observational study (PMOS) Protocol
Effectiveness of Adalimumab (HUMIRA®)
Psoriatic Arthritis
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 31, 2014