A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis

NCT04574492 | Completed

• 1 other identifier: P20-096
• Study Type: observational
• Target: 413
• Locations: 1 country
• Sites: 39

Brief Summary

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada. Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis; Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve Clinical Remission

  Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\<2.6.

  At Month 6

Secondary Outcomes (20)

• Change in Pain Using Visual Analogue Scale (VAS)

  Baseline (Month 0) Through Month 24

• Duration of Morning Stiffness

  Baseline (Month 0) Through Month 24

• Severity of Morning Stiffness

  Baseline (Month 0) Through Month 24

• Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

  Baseline (Month 0) Through Month 24

• Percentage of Participants Achieving Clinical Remission

  Baseline (Month 0) Through Month 24

Study Arms (1)

Participants receiving Upadacitinib

Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).

You may qualify if:

• Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator.
• Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study.
• Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups:
• Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARD).
• Has not been previously exposed to tsDMARD and has been previously exposed to \<= 2 bDMARDs.
• Has been previously treated with one tsDMARD and \<=1 bDMARD prior to treatment with that tsDMARD.

You may not qualify if:

• Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the treatment of RA.
• Diagnosis of rheumatic disease other than RA.
• Diagnosis of juvenile RA.
• Currently participating in an investigational clinical trial.
• Has prior exposure to a bDMARD after exposure to a tsDMARD.
• Has prior exposure to tsDMARD in an investigational clinical trial.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (39)

Rheumatology Research Associates /ID# 224534

Edmonton, Alberta, T5M 0H4, Canada

Location

Saurash Reddy Professional Corporation /ID# 225288

Edmonton, Alberta, T6G 0T2, Canada

Location

Fraser Clinical Trials Inc /ID# 225200

New Westminster, British Columbia, V3L 3W4, Canada

Location

Dr. Jonathan D. Chan Inc. /ID# 222976

Vancouver, British Columbia, V5Z 1J9, Canada

Location

Dr. Milton F. Baker Inc. /ID# 224555

Victoria, British Columbia, V8P 5P6, Canada

Location

Manitoba Clinic /ID# 223288

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Eastern Regional Health Authority /ID# 223911

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nexus Clinical Research /ID# 225896

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

Location

Dr. Juris Lazovskis Inc. /ID# 224817

Sydney, Nova Scotia, B1S 3N1, Canada

Location

Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536

Ancaster, Ontario, L9G 3K9, Canada

Location

Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366

Brampton, Ontario, L6R 0W3, Canada

Location

Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952

Burlington, Ontario, L7R 2H3, Canada

Location

Paolo Pace Medicine Professional Corporation /ID# 234057

Cambridge, Ontario, N1R 4S1, Canada

Location

Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814

Dundas, Ontario, L9H 1B7, Canada

Location

Arthur Karasik Medicine Professional Corporation /ID# 225276

Etobicoke, Ontario, M9C 5N2, Canada

Location

Adachi Medicine Prof. Corp /ID# 223872

Hamilton, Ontario, L8N 1Y2, Canada

Location

St. Joseph's Healthcare /ID# 224042

Hamilton, Ontario, L8N 4A6, Canada

Location

West Mountain Medical Center /ID# 222975

Hamilton, Ontario, L9C 5N2, Canada

Location

Brandusa Florica Medicine Professional Corporation /ID# 222173

Mississauga, Ontario, L5A 3V8, Canada

Location

Credit Valley Rheumatology /ID# 219226

Mississauga, Ontario, L5M 2V8, Canada

Location

Imtiaz MS Khan Medicine Prof /ID# 225275

Mississauga, Ontario, L5M 4N4, Canada

Location

Rajwinder S. Dhillon Medicine /ID# 224365

Niagara Falls, Ontario, L2E 6A6, Canada

Location

Makhzoum Medicine Professional Corporation /Id# 229629

Oakville, Ontario, L6H 3P1, Canada

Location

Dr. S. Gill Medicine Professional Corporation /ID# 225238

Oakville, Ontario, L6M 1M1, Canada

Location

The Waterside Clinic /ID# 224205

Orillia, Ontario, L3V 1T5, Canada

Location

Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645

Oshawa, Ontario, L1H 1B9, Canada

Location

Angela Montgomery Medicine Professional Corporation /ID# 231142

Ottawa, Ontario, K1H 7X3, Canada

Location

Niagara Peninsula Arthritis Ct /ID# 221472

St. Catharines, Ontario, L2N 7E4, Canada

Location

Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797

Windsor, Ontario, N8X 1T3, Canada

Location

CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021

Montreal, Quebec, H1T 2M4, Canada

Location

Rheumatology Institute of Montreal /ID# 224045

Montreal, Quebec, H2L 1S6, Canada

Location

Applied Medical Informatics Research Inc. (AMIR) /ID# 224321

Montreal, Quebec, H4A 3T2, Canada

Location

Clinique de Rhumatologie de Montreal /ID# 221266

Montreal, Quebec, H4N 1C6, Canada

Location

CISSSBSL -Hopital regional de Rimouski /ID# 224681

Rimouski, Quebec, G5L 5T1, Canada

Location

Groupe de Recherche en Maladies Osseuses Inc /ID# 222977

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

CIUSSS de l'Estrie - CHUS /ID# 225404

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Centre de Recherche Musculo-Squelettique /ID# 224513

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Dr Naik-Medical Professional Corporation-Alliance Health /ID# 221195

Saskatoon, Saskatchewan, S7H 5M7, Canada

Location

Rheumatology Associates /ID# 228584

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Related Publications (1)

• Bessette L, Chan J, Chow A, Lisnevskaia L, Richard N, Fournier PA, Liazoghli D, Girard T, Haaland D. Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study. Rheumatol Ther. 2024 Jun;11(3):563-582. doi: 10.1007/s40744-024-00651-8. Epub 2024 Mar 11.

  PMID: 38467912 DERIVED

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune 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: September 29, 2020
• First Posted: October 5, 2020
• Study Start: October 7, 2020
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CA (39)