A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

NCT ID: NCT02046616

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-28
• Study Completion Date: 2016-09-13

Brief Summary

This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab Alone or Combined with Methotrexate or Other DMARD

All participants will receive tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs, irrespective of body weight, for 24 weeks.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Tocilizumab 162 mg will be administered subcutaneously QW.

Methotrexate

Intervention Type: DRUG

Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Non-Biologic DMARDs

Intervention Type: DRUG

Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Interventions

Tocilizumab

Tocilizumab 162 mg will be administered subcutaneously QW.

Intervention Type: DRUG

Methotrexate

Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Intervention Type: DRUG

Non-Biologic DMARDs

Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Intervention Type: DRUG

Other Intervention Names

RoActemra, Actemra

Eligibility Criteria

Inclusion Criteria

• Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
• Moderate to severe RA with a DAS28-ESR score >3.2 points
• Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
• Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
• Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
• Receiving treatment on an outpatient basis, not including tocilizumab
• Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential

Exclusion Criteria

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
• Rheumatic autoimmune disease other than RA
• Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
• Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
• Prior history of or current inflammatory joint disease other than RA
• Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
• Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
• Evidence of serious concomitant disease or disorder
• Known active current or history of recurrent infection
• Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
• Active tuberculosis requiring treatment within the previous 3 years
• Positive for hepatitis B or hepatitis C
• History of or current active primary or secondary immunodeficiency
• Pregnant or lactating women
• Neuropathies or other conditions that might interfere with pain evaluation
• Inadequate hematologic, renal, or liver function

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Aalborg Universitetshospital Nord, Reumatologisk Afdeling

Aalborg, , Denmark

Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet

Glostrup Municipality, , Denmark

Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme

Hellerup, , Denmark

Holbæk Sygehus, Medicinsk Afd., Reumatologisk Amb.15-2

Holbæk, , Denmark

Sjællands Universitetshospital, Køge; Reumatologisk Afdeling

Køge, , Denmark

Odense Universitetshospital, Reumatologisk Afdeling C, Ambulatoriet

Odense, , Denmark

Svendborg Sygehus, Reumatologisk Ambulatorium

Svendborg, , Denmark

Helsinki University Central Hospital; Rheumatology Clinic

Helsinki, , Finland

Kiljavan Lääketutkimus Oy

Hyvinkää, , Finland

Central Hospital of Pohjois-Karjala; Outpatient Clinic of Rheumatology

Joensuu, , Finland

Keski-Suomen Keskussairaala; Sisätautien Klinikka

Jyväskylä, , Finland

Lappeenranta Central Hospital; Outpatient Clinic of Internal Medicine

Lappeenranta, , Finland

Oulu University Hospital; Rheumatology

Oulu, , Finland

Ålesund Sykehus; Revmatologisk Avdeling

Ålesund, , Norway

Haukeland Universitetssykehus; Revmatologisk Avdeling

Bergen, , Norway

Drammen sykehus Vestre Viken HF, Revmatologisk avd.

Drammen, , Norway

Diakonhjemmet; Reumatolgisk Avdeling

Oslo, , Norway

St. Olavs Hospital; Revmatologisk avdeling

Trondheim, , Norway

Länssjukhuset Ryhov; Ortoped- och Reumatolog kliniken

Jönköping, , Sweden

Uni Hospital Linkoeping; Dept. of Rheumatology

Linköping, , Sweden

Skånes Universitetssjukhus Lund; Reumatologkliniken

Lund, , Sweden

Skånes Universitetssjukhus Malmö; Reumatologkliniken

Malmo, , Sweden

Örebro Uni Hospital; Rheumatology

Örebro, , Sweden

Simrishamns Sjukhus

Simrishamn, , Sweden

Karolinska Sjukhuset; Reumatologkliniken D2-1

Stockholm, , Sweden

Akademiska sjukhuset, Reumatologkliniken

Uppsala, , Sweden

Västmanlands sjukhus Västerås, Reumatologkliniken

Västerås, , Sweden

Countries

Denmark; Finland; Norway; Sweden

References

Hammer HB, Jensen Hansen IM, Jarvinen P, Leirisalo-Repo M, Ziegelasch M, Agular B, Terslev L. Rheumatoid arthritis patients with predominantly tender joints rarely achieve clinical remission despite being in ultrasound remission. Rheumatol Adv Pract. 2021 May 14;5(2):rkab030. doi: 10.1093/rap/rkab030. eCollection 2021.

Reference Type: DERIVED

PMID: 34131623 (View on PubMed)

Hammer HB, Hansen I, Jarvinen P, Leirisalo-Repo M, Ziegelasch M, Agular B, Terslev L. Major reduction of ultrasound-detected synovitis during subcutaneous tocilizumab treatment: results from a multicentre 24 week study of patients with rheumatoid arthritis. Scand J Rheumatol. 2021 Jul;50(4):262-270. doi: 10.1080/03009742.2020.1845394. Epub 2021 Jan 19.

Reference Type: DERIVED

PMID: 33464147 (View on PubMed)

Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

Reference Type: DERIVED

PMID: 30649524 (View on PubMed)

Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.

Reference Type: DERIVED

PMID: 29244149 (View on PubMed)

Other Identifiers

2013-002007-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28691

Identifier Type: -

Identifier Source: org_study_id