Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT02362074
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis P @ Work
• Scientific title: Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis.
• Date of first enrolment: January 21, 2015
• Target sample size: 401
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02362074
• Study type: Observational

Countries of recruitment

Canada

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects with moderate to severe RA for whom the physician has decided to initiate
treatment with adalimumab

2. Adult male or female = 18 years old that has been newly prescribed adalimumab therapy
according to the local product label and are with PROGRESS

3. Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active
and latent TB

4. Subject is able to give written patient authorization and is willing to comply with
the requirements of this study protocol.

Exclusion Criteria:

1. Subject cannot or will not sign a patient authorization

2. Subject with a known hypersensitivity to Adalimumab, or any of its components

3. Presence of any condition that, in the opinion of the treating physician, prohibits
the subject from participating in the study or obscures the assessment of the
treatment of RA

4. Subjects currently participating in an investigational clinical trial

5. Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs)
for RA. Any prior treatment with adalimumab is prohibited

6. Subjects previously treated with targeted synthetic disease modifying agent.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Primary Outcome(s)

Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS) [Time Frame: From Month 0 to Month 6]

Change in Financial Loss [Time Frame: From Month 0 to Month 6]

Secondary Outcome(s)

Change in Health Assessment Questionnaire (HAQ) [Time Frame: From Month 0 to Month 24]

Change in the Financial Loss [Time Frame: From Month 0 to Month 12, 18 and 24]

Change in Swollen Joint Count (SJC) [Time Frame: From Month 0 to Month 24]

Rate of Remission Per Clinical Disease Activity Index (CDAI) [Time Frame: From Month 0 to Month 24]

Change in patient pain [Time Frame: From Month 0 to Month 24]

Change in Disease Activity Score (DAS) 28 [Time Frame: From Month 0 to Month 24]

Change in Rheumatoid Arthritis-Work Instability (RA-WIS) [Time Frame: From Month 0 to Month 12, 18 and 24]

Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR) [Time Frame: From Month 0 to Month 24]

Change in patient assessment of Global Disease Activity [Time Frame: From Month 0 to Month 24]

Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28 [Time Frame: From Month 0 to Month 24]

Rate of Achieving Low Disease Activity (LDA) per CDAI [Time Frame: From Month 0 to Month 24]

Change in Tender Joint Count (TJC) [Time Frame: From Month 0 to Month 24]

Rate of Achieving Low Disease Activity (LDA) per SDAI [Time Frame: From Month 0 to Month 24]

Change in physician's assessment of Global Disease Activity [Time Frame: From Month 0 to Month 24]

Rate of Remission per Disease Activity Scale (DAS) 28 [Time Frame: From Month 0 to Month 24]

Rate of Remission per Simplified Disease Activity Index (SDAI) [Time Frame: From Month 0 to Month 24]

Secondary ID(s)

P14-455

Source(s) of Monetary Support

Please refer to primary and secondary sponsors