NCT02362074

Brief Summary

The purpose of this study is to describe the impact of treatment with adalimumab on work related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated in Canada.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

5.1 years

First QC Date

February 9, 2015

Last Update Submit

February 9, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)

    This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.

    From Month 0 to Month 6

  • Change in Financial Loss

    This is patient reported assessment of financial burden of RA.

    From Month 0 to Month 6

Secondary Outcomes (16)

  • Change in Rheumatoid Arthritis-Work Instability (RA-WIS)

    From Month 0 to Month 12, 18 and 24

  • Change in the Financial Loss

    From Month 0 to Month 12, 18 and 24

  • Change in patient pain

    From Month 0 to Month 24

  • Change in Tender Joint Count (TJC)

    From Month 0 to Month 24

  • Change in Disease Activity Score (DAS) 28

    From Month 0 to Month 24

  • +11 more secondary outcomes

Study Arms (1)

Adalimumab subjects

Subjects starting Adalimumab treatment at time of enrollment.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a Multi-Center Canadian Observational Study that will enroll rheumatoid arthristis (RA) subjects for whom the treating physician has decided to treat with adalimumab.

You may qualify if:

  • Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
  • Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
  • Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
  • Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.

You may not qualify if:

  • Subject cannot or will not sign a patient authorization
  • Subject with a known hypersensitivity to Adalimumab, or any of its components
  • 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
  • Subjects currently participating in an investigational clinical trial
  • Subjects treated with \>1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
  • Subjects previously treated with targeted synthetic disease modifying agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Pont, Cranbrook, BC, CA /ID# 134511

Cranbrook, British Columbia, V1C 2R7, Canada

Location

Drs. M & W Teo Inc. /ID# 148641

Penticton, British Columbia, V2A 4Z1, Canada

Location

The Arthritis Research Center /ID# 147466

Vancouver, British Columbia, V5Z 1L7, Canada

Location

Kur, Vancouver, CA /ID# 135371

Vancouver, British Columbia, V5Z 3Y1, Canada

Location

Manitoba Clinic /ID# 134830

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Nexus Clinical Research /ID# 135411

St. John's, Newfoundland and Labrador, A1B 5E8, Canada

Location

St. Clare's Mercy Hospital /ID# 136737

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Dr. Juris Lazovskis Inc. /ID# 134510

Sydney, Nova Scotia, B1S 3N1, Canada

Location

Waterside Clinique /ID# 134190

Barrie, Ontario, L4M 6L2, Canada

Location

Drs Nalin and Vandana Ahluwali /ID# 136485

Brampton, Ontario, L6T 0G1, Canada

Location

Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486

Burlington, Ontario, L7L 0B7, Canada

Location

Dr. Chrisotomor Kouroukis & Dr /ID# 151189

Dundas, Ontario, L9H 1B7, Canada

Location

Adachi Medicine Prof. Corp /ID# 152538

Hamilton, Ontario, L8N 1Y2, Canada

Location

West Mountain Medical Center /ID# 134832

Hamilton, Ontario, L9C 5N2, Canada

Location

Dr. Martin M.S. Lee Med Prof C /ID# 138333

Mississauga, Ontario, L5A 1W4, Canada

Location

Brandusa Florica Med Prof Corp /ID# 134829

Mississauga, Ontario, L5A 3V8, Canada

Location

Montgomery, Mississauga, CA /ID# 136943

Mississauga, Ontario, L5A 3V8, Canada

Location

Credit Valley Rheumatology /ID# 134834

Mississauga, Ontario, L5M 2V8, Canada

Location

Rajwinder S. Dhillon Medicine /ID# 147756

Niagara Falls, Ontario, L2E 6A6, Canada

Location

Capital North Therapeutics Res /ID# 134835

Ottawa, Ontario, K1Y 4G2, Canada

Location

Setty, Owen Sound, CA /ID# 134189

Owen Sound, Ontario, N4K 1S4, Canada

Location

The Medical Centre /ID# 134833

Peterborough, Ontario, K9J 7B3, Canada

Location

Involved Medicine /ID# 163880

Toronto, Ontario, M3H 5S4, Canada

Location

Dr. Samuel K Silverberg /ID# 136496

Toronto, Ontario, M9V 4B8, Canada

Location

Institut de Rhum. de Montreal /ID# 135289

Montreal, Quebec, H2L 1S6, Canada

Location

Jewish General Hospital /ID# 204168

Montreal, Quebec, H3T 1E2, Canada

Location

PSS Medical Inc. /ID# 134193

Montreal, Quebec, H3T 1Y3, Canada

Location

Clinique de Rhumatologie de Montréal /ID# 162186

Montreal, Quebec, H4N 1C6, Canada

Location

Ctr. de Rheum de l'est du QC /ID# 135410

Rimouski, Quebec, G5L 8W1, Canada

Location

Rheum Disease Ctr of Montreal /ID# 135372

Westmount, Quebec, H3Z 2Z3, Canada

Location

Dr. Latha Naik /ID# 135813

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

Chuq - Chul /Id# 137054

Québec, G1V 4G2, Canada

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 12, 2015

Study Start

January 21, 2015

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations