An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis

March 9, 2023 updated by: Hoffmann-La Roche

A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

This open-label, single arm, multicenter long-term extension study of WA19926 evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
      • Moscow, Russian Federation, 115522
      • Moscow, Russian Federation, 119049
      • Moscow, Russian Federation, 105203
      • Moscow, Russian Federation, 115682
      • Moscow, Russian Federation, 129327
      • Ryazan, Russian Federation, 390011
      • Saint-Petersburg, Russian Federation, 195067
      • Saratov, Russian Federation, 410002
      • Tula, Russian Federation, 300053
      • Voronezh, Russian Federation, 394066
      • Yaroslavl, Russian Federation, 150030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
  • No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
  • Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period

Exclusion Criteria:

  • Pregnant females
  • Participants who have withdrawn prematurely from the WA19926 core study for any reason
  • Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
  • Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
  • Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
  • Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
  • Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
  • Evidence of severe uncontrolled concomitant disease or disorder
  • Known active or history of recurrent infections
  • Active tuberculosis requiring treatment in the previous 3 years
  • History of alcohol, drug or chemical abuse since inclusion in the WA19926 study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tocilizumab
Drug: Tocilizumab
8 mg/kg administered intravenously (IV) every 4 weeks for 104 weeks
Other Names:
  • RoActemra
  • Actemra

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)
Time Frame: Up to 112 weeks
An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. AESIs included serious infections (including opportunistic infections) and abnormal liver function tests.
Up to 112 weeks
Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal
Time Frame: Up to 112 weeks
An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE.
Up to 112 weeks
Percentage of Adverse Events With Severity as Mild, Moderate, and Severe
Time Frame: Up to 112 weeks
Up to 112 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in the Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
The DAS28-ESR Scale is a measure of a participant's disease activity. It is based on tender joint count (28 joints), swollen joint count (28 joints), a participant's assessment of disease activity, and erythrocyte sedimentation rate. DAS28-ESR is expressed as a score on a scale with a minimum score of 0 (low disease activity ) to a maximum score of 10 (high disease activity). A negative mean percent change from baseline indicates a decrease in disease activity, and a positive mean percent change from baseline indicates an increase in disease activity.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Percent Change From Baseline in the Simplified Disease Activity Index (SDAI) Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
The Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC), based on a 28-joint assessment, patient and physician global assessment assessed on 0-10 centimeter (cm) visual analogue scale (VAS), where 0 = no disease activity and 10 = worst disease activity, and level of C-reactive protein (CRP, mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. A negative mean percent change from baseline indicates a decrease in disease activity, and a positive mean percent change from baseline indicates an increase in disease activity.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Change From Baseline in Tender Joint Count 66 (TJC 66) Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Number of tender joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Change From Baseline in Swollen Joint Count 66 (SJC 66) Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Number of swollen joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Percentage of Participants With Treatment-Free Remission According to DAS28-ESR/SDAI Remission Criteria
Time Frame: Up to 104 weeks
Treatment-free remission is remission at two consecutive assessment visits (every 12 weeks) after discontinuing study drug on the second assessment visit. Clinical remission is DAS28-ESR score <2.6 and/or SDAI score ≤3.3. The DAS28-ESR scale is a measure of a participant's disease activity based on tender joint count (28 joints), swollen joint count (28 joints), a participant's assessment of disease activity, and ESR. DAS28-ESR scored on a scale with a minimum score of 0 (low disease activity) to a maximum score of 10 (high disease activity). The SDAI is sum of TJC and SJC, based on a 28-joint assessment, patient and physician global assessment assessed on 0-10 centimeter visual analogue scale (VAS), where 0 = no disease activity and 10 = worst disease activity, and level of C-reactive protein (CRP, mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high (or severe) disease activity.
Up to 104 weeks
Time to Rheumatoid Arthritis Recurrence in Participants Who Achieved Treatment-Free Remission
Time Frame: Up to 104 weeks
Time to rheumatoid arthritis (RA) recurrence = period from treatment-free remission to RA recurrence. RA recurrence was worsening of disease activity with treatment beyond supportive therapy.
Up to 104 weeks
Percent Change in Participant's General Assessment of Disease Activity (Severity of Disease) VAS Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
The participant's overall assessment of their current disease activity was displayed on a 100-millimeter (mm) horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity" (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Percent Change in Participant's Assessment of Pain (VAS) Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Participants' pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Change From Baseline in Health Assessment Questionnaire (HAQ-DI) Score Over Time
Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML28124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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