A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.

Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002363-15-IS

Enrollment

Registered

2011-06-22

Start date

2011-08-17

Completion date

Unknown

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: RoActemra® Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or non-pregnant, non-nursing female 2. = 18 years of age 3. Receiving treatment on an outpatient basis 4. RA of = 6 months duration 5. Moderate to severe active RA: (DAS28 = 3.2) 6. Patients on = 1 non-biologic DMARDs and/or TNF?-inhibitor at a stable dose for a period = 8 weeks prior to treatment 7. Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy 8. If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment 9. Able and willing to give written informed consent and comply with the requirements of the study protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization 2. Rheumatic autoimmune disease other than rheumatoid arthritis 3. Functional class IV as defined by the ACR Classification of Functional Status in 4. Prior history of or current inflammatory joint disease other than RA Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening 5. Previous treatment with rituximab and abatacept 6. Pregnant women or nursing (breastfeeding) mothers 7. Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD 8. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 9. Preivious treatment with any cell-depleting therapy 10. Preivious treatment with any tocilizumab 11. History of or currently active primary or secondary immunodeficiency 12. Known active current og history of recurrent infection (incliding TB) 13. Body weight of > 150 kg

Design outcomes

Primary

Measure	Time frame
Secondary Objective: • To assess the incidence of discontinuations of TCZ due to AE and due to other causes. • To assess the incidence of increase in ALT, AST and lipids • To assess the number and % of patients achieving clinical remission (DAS28 < 2.6), LDA after 24 weeks. • To assess the number and % of patients achieving ACR20, ACR50, ACR70 and ACR90 after 24 weeks • To assess increase in HAQ after 24 weeks ;Primary end point(s): Infusion reactions as defined for the pivotale phase III trials. Infusion reactions are defined as any reaction that occurs during the infusion of tocilizumab or during the first 24 hours after the infusion. ;Timepoint(s) of evaluation of this end point: At every study visit;Main Objective: Incidence of infusion reactions	—

Measure

Time frame

Secondary Objective: • To assess the incidence of discontinuations of TCZ due to AE and due to other causes. • To assess the incidence of increase in ALT, AST and lipids • To assess the number and % of patients achieving clinical remission (DAS28 < 2.6), LDA after 24 weeks. • To assess the number and % of patients achieving ACR20, ACR50, ACR70 and ACR90 after 24 weeks • To assess increase in HAQ after 24 weeks ;Primary end point(s): Infusion reactions as defined for the pivotale phase III trials. Infusion reactions are defined as any reaction that occurs during the infusion of tocilizumab or during the first 24 hours after the infusion. ;Timepoint(s) of evaluation of this end point: At every study visit;Main Objective: Incidence of infusion reactions

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Secondary

Measure	Time frame
Secondary end point(s): Safety o The number and percentage of patients, where the administration of tocilizumab was stopped due to adverse events and serious adverse events. o The number and percentage of patients, where the administration of tocilizumab was stopped for other reasons. o The number and percentage of patients with increased levels of ALT or AST > 1.5 ULN, > 3 ULN and > 5 ULN at any visits. o The number and percentage of patients with elevated levels of lipids, according to the guidelines for ATP III at any visits. Efficacy o The number and percentage of patients who achieved a significant clinical improvement in disease activity score 28, DAS28 (reductions of at least 1,2 units) per visit. o The number and percentage of patients who achieved low disease activity (DAS28 < 3,2) per visit. o The number and percentage of patients who achieved DAS28 remission (DAS28 < 2,6) per visit. o Average (or median) and SD (or quartiles) for DAS28 per visit. o The number and percentage of patients who achieved ACR20, ACR50, ACR70 and ACR90 at any visit. o Average (or median) and SD (or quartiles) for hsCRP per visit. o Average (or median) and SD (or quartiles) of HAQ per visit. o The number and percentage of patients who achieved a significant clinical HAQ-response, defined as an improvement of at least 0,22 units compared to baseline on HAQ-scale per visit. ;Timepoint(s) of evaluation of this end point: Safety and efficacy evaluations will be done at every visit	—

Measure

Time frame

Secondary end point(s): Safety o The number and percentage of patients, where the administration of tocilizumab was stopped due to adverse events and serious adverse events. o The number and percentage of patients, where the administration of tocilizumab was stopped for other reasons. o The number and percentage of patients with increased levels of ALT or AST > 1.5 ULN, > 3 ULN and > 5 ULN at any visits. o The number and percentage of patients with elevated levels of lipids, according to the guidelines for ATP III at any visits. Efficacy o The number and percentage of patients who achieved a significant clinical improvement in disease activity score 28, DAS28 (reductions of at least 1,2 units) per visit. o The number and percentage of patients who achieved low disease activity (DAS28 < 3,2) per visit. o The number and percentage of patients who achieved DAS28 remission (DAS28 < 2,6) per visit. o Average (or median) and SD (or quartiles) for DAS28 per visit. o The number and percentage of patients who achieved ACR20, ACR50, ACR70 and ACR90 at any visit. o Average (or median) and SD (or quartiles) for hsCRP per visit. o Average (or median) and SD (or quartiles) of HAQ per visit. o The number and percentage of patients who achieved a significant clinical HAQ-response, defined as an improvement of at least 0,22 units compared to baseline on HAQ-scale per visit. ;Timepoint(s) of evaluation of this end point: Safety and efficacy evaluations will be done at every visit

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Countries

Denmark, Iceland

Contacts

Public ContactMedical Manager Birte Agular

Roche a/s

birte.agular@roche.com004536399839

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026