Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

This study is currently recruiting participants.
Verified February 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01782469
First received: January 31, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This Post-Marketing Observational Study (PMOS) aims to assess the effectiveness of Adalimumab on reducing synovitis This is assessed by ultrasonography in Rheumatoid Arthritis (RA) patients in Egypt. The study will collect B-mode ultrasonography data from RA patients who are on Adalimumab and have not been treated with any other anti-TNF therapy in the past.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multi-center, Post-marketing Observational Study on Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography on Egyptian Population

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • The average change in synovitis measured by B-modal Ultrasonography assessment score after 13 weeks of treatment with Adalimumab. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Presence of synovitis and joint fluid is scored on a scale from 0 to 3 (0=none,1=minor,2=moderate,3=major presence). The sum of scores of all 12 joints will be taken as the ultrasonography assessment score (giving a score range of 0 - 36). The 12 joints to be assessed are elbow, wrist, second MCP, third MCP, knee and ankle, all on both sides.


Secondary Outcome Measures:
  • The mean change in ultrasonography assessment score from Screening through Week12 [ Time Frame: From Week 0 to Week 12 ] [ Designated as safety issue: No ]
    (on a scale from 0 - 3 for each joint) and the sum of all 12 joint scores (on a scale from 0 - 36).

  • The mean number of joints with detected erosions between Week 0 and Week 12 [ Time Frame: From Week 0 to Week 12 ] [ Designated as safety issue: No ]
    Number of joints with detected synovitis and/or erosion ultrasonography

  • Percentage of patients who achieved an ACR20 response at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Tender joint count (TJC), swollen joint count (SJC), patient assessment of pain, patient assessment of disease activity, physician assessment of disease activity

  • The mean change in Health Assessment Questionnaire (HAQ) score [ Time Frame: From Week 0 to Week 12 ] [ Designated as safety issue: No ]
    on a scale from 0 to 3, where 0 means no difficulty and 3 means unable to perform activity


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthritis (RA) patients
Male or female patients at least 18 years of age with diagnosis of RA

Detailed Description:

The purpose of this study is to evaluate the changes in synovitis of Egyptian rheumatoid arthritis patients who are on Adalimumab.

A sample size of 60 patients is targeted. The number of sites targeted is around 5 sites with approximately 12 patients per site.

Patients are observed over a period of maximum 13 weeks of treatment with Adalimumab during which a maximum of 5 visits are performed.

Analysis will be performed on the intention-to-treat population. Missing data will be counted as missed and patients whose ultrasonography or appropriate American College of Rheumatology (ACR) assessments are missing will be ignored from the analysis of the assessment for which data was missing.

All variables recorded during the study will be summarized. Absolute and relative frequencies will be provided for categorical endpoints. Mean, standard deviation, median, quartiles, minimum and maximum will be provided for continuous endpoints. Two-sided 95% confidence intervals will be provided as appropriate. All adverse events reported during the study will be tabulated using frequency tables with intensity and actions taken.

  Eligibility

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

Private clinics

Criteria

Inclusion Criteria:

A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:

  • Male or Female patients ≥ 18 years of age with diagnosis of RA
  • Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines
  • Patient is naïve to all biologics e.g. anti-CD4 and anti-TNF treatments at the start of the study
  • Patient has no history of inflammatory arthritis other than rheumatoid arthritis
  • Patient has no history of lymphoma or leukemia or other malignancies
  • Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion Criteria:

  • Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria
  • Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression
  • Susceptibility to infections including TB, as judged by the investigator
  • Patient is carrier of Hepatitis B virus
  • Patient is a pregnant or lactating female at the time of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782469

Contacts
Contact: Rasha Eldessouky, MD rasha.eldessouky@abbott.com
Contact: Bhadrish Valabah, MD bhadrish.vallabh@abbott.com

Locations
Egypt
Site Reference ID/Investigator# 95896 Not yet recruiting
Cairo, Egypt, 11311
Principal Investigator: Site Reference ID/Investigator# 95896         
Site Reference ID/Investigator# 95897 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 95897         
Site Reference ID/Investigator# 95898 Not yet recruiting
Cairo, Egypt, 11341
Principal Investigator: Site Reference ID/Investigator# 95898         
Site Reference ID/Investigator# 95899 Not yet recruiting
Cairo, Egypt
Principal Investigator: Site Reference ID/Investigator# 95899         
Site Reference ID/Investigator# 75093 Recruiting
Giza, Egypt, 12411
Principal Investigator: Site Reference ID/Investigator# 75093         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rasha Eldessouky, MD Abbott (Egypt)
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01782469     History of Changes
Other Study ID Numbers: P13-708
Study First Received: January 31, 2013
Last Updated: February 27, 2014
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by AbbVie:
Synovitis
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Synovitis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014