Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

NCT03112213 | Completed FDA Drug

• 1 other identifier: ML30088
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 27

Brief Summary

This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous \[SC\] or intravenous \[IV\]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration

  Day -14 to Day 0 (Baseline)

• Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration

  14 days after 6-8 weeks of tocilizumab administration

• Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration

  14 days after 12-16 weeks of tocilizumab administration

• Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration

  NSAIDs high-dose refers to mean defined daily dose (DDD) greater than (\>) 100 percent (%) and low-dose refers to mean DDD lesser than or equal to (\</=) 100%.

  Day -14 to Day 0 (Baseline)

• Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration

  NSAIDs high-dose refers to mean DDD \>100% and low-dose refers to mean DDD \</=100%.

  14 days after 6-8 weeks of tocilizumab administration

• Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration

  NSAIDs high-dose refers to mean DDD \>100% and low-dose refers to mean DDD \</=100%.

  14 days after 12-16 weeks of tocilizumab administration

Secondary Outcomes (14)

• Percentage of Participants Who Take NSAIDs

  Day -14 up to approximately Day 126

• Average Daily Dose of NSAIDs

  Day -14 up to approximately Day 126

• Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors

  Day -14 up to approximately Day 126

• Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs

  Day -14 up to approximately Day 126

• Percentage of NSAID-Prescribers

  Day -14 up to approximately Day 126

Study Arms (1)

Participants With RA

Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.

Drug: Tocilizumab; Drug: NSAIDs

Interventions

Tocilizumab DRUG

Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.

Also known as: RoACTEMRA®

Participants With RA

NSAIDs DRUG

Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

Participants With RA

Eligibility Criteria

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

You may qualify if:

• Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV)
• Current users of NSAIDs due to RA as assessed by the physician

You may not qualify if:

• Contraindications to treatment with tocilizumab as per SPC
• Prior therapy with tocilizumab

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (27)

Rheumazentrum Kupka

Altenburg, 04600, Germany

Location

Praxis für Rheumatologie.

Amberg, 92224, Germany

Location

Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

Bad Nauheim, 61231, Germany

Location

Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

Berlin, 10117, Germany

Location

Praxis für Innere Medizin - Rheumatologie

Berlin, 12435, Germany

Location

Rheuma Praxis Berlin Sven Remstedt

Berlin, 12435, Germany

Location

Praxis Dr. Silke Zinke

Berlin, 13055, Germany

Location

Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken

Burghausen, 84489, Germany

Location

Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

Dresden, 01307, Germany

Location

Praxis Dr. med. Semmler; Facharzt für Innere Medizin

Güstrow, 18273, Germany

Location

Dres.Karin Babinsky und Anke Liebhaber

Halle, 06128, Germany

Location

Rheumatologische Schwerpunktpraxis

Hanover, 30161, Germany

Location

Rheumapraxis PD Dr.med. Bernhard Heilig

Heidelberg, 69120, Germany

Location

Rheumatologische Facharztpraxis Maren Sieburg

Magdeburg, 39104, Germany

Location

Praxis für Innere Medizin und Rheumatologie

Mansfeld, 06343, Germany

Location

Praxis Prof. Dr.med. Herbert Kellner

München, 80935, Germany

Location

Praxiszentrum St. Bonifatius

München, 81541, Germany

Location

Rheumatologische Praxis

Neubrandenburg, 17033, Germany

Location

Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg

Neuss, 41460, Germany

Location

Praxis Dr.med. Christoph Volberg

Neuss, 41462, Germany

Location

Praxis Dr. Albert

Offenburg, 77652, Germany

Location

Praxis für Rheumatologie Dr. med. Hauke E. Heintz

Poppenbüttel, 22391, Germany

Location

Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen

Püttlingen, 66346, Germany

Location

Rheumazentrum Ratingen - Studienambulanz

Ratingen, 40878, Germany

Location

Praxis Dr.med. Werner A. Biewer

Saarbrücken, 66111, Germany

Location

Rheumatologische Schwerpunktpraxis am Feuersee

Stuttgart, 70178, Germany

Location

Praxis für Rheumatologie

Ulm, 89073, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: January 12, 2017
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

DE (27)