Rheumatoid ArthritisPhase 3NCT01649804
A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis
A Phase 3 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 3 sites in Hungary.
Trial summary
This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- tocilizumab [RoActemra/Actemra]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesHungary
- Study dates
- Jul 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants, >/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
- No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
- Receiving treatment on an outpatient basis
Who cannot join
- Females who are pregnant
- Participants who have prematurely withdrawn from the core study WA19926 for any reason
- Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
- Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
- Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
- Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- Abnormal laboratory values
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites
Study site
Budapest, 1027
Study site
Debrecen, 4032
Study site
Eger, 3300
About this study
Official title: 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 extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.
- Conditions
- Rheumatoid Arthritis
- Being tested
- tocilizumab [RoActemra/Actemra]
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tocilizumab [RoActemra/Actemra]Drug
8 mg/kg intravenously every 4 weeks for 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| RoActemra/Actemra single arm | Experimental | Not described Receives: Drug: tocilizumab [RoActemra/Actemra] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. 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. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.
Measured: End of Study (Week 104 or early withdrawal)
Secondary outcomes (8)
Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)
The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
Measured: Screening and End of Study (Week 104 or early withdrawal)
Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)
The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. 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.
Measured: Screening and End of Study (Week 104 or early withdrawal)
Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)
Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness.
Measured: Week 12 and Week 104
Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)
Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling.
Measured: Week 12 and Week 104
Time to Rheumatoid Arthritis (RA) Flare
RA flare was defined as any worsening of the participant's disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit.
Measured: End of Study (Week 104 or early withdrawal)
Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity
The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad.
Measured: Week 12 and Week 104
Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain
A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm).
Measured: Week 12 and Week 104
Health Assessment Questionnaire Disability Index (HAQ-DI)
The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty.
Measured: End of Study (Week 104 or early withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649804
- Sponsor's protocol ID
- ML28146
- Other IDs
- 2011-006125-14
- Status last verified
- Sep 2016
- First submitted
- 23 Jul 2012
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01649804
- Acronym / sponsor ID
- ML28146
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Posted 22 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RoActemra/Actemra single arm | Experimental | Drug: tocilizumab [RoActemra/Actemra] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult participants, >/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
- No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
- Receiving treatment on an outpatient basis
Key exclusion criteria (7 listed)
- Females who are pregnant
- Participants who have prematurely withdrawn from the core study WA19926 for any reason
- Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
- Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
- Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tocilizumab [RoActemra/Actemra]8 mg/kg intravenously every 4 weeks for 104 weeks | Drug | RoActemra/Actemra single arm |
Primary outcome
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Time frame: End of Study (Week 104 or early withdrawal)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. 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. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.
8 secondary outcomes
Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)
Time frame: Screening and End of Study (Week 104 or early withdrawal)
Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)
Time frame: Screening and End of Study (Week 104 or early withdrawal)
Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)
Time frame: Week 12 and Week 104
Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)
Time frame: Week 12 and Week 104
Time to Rheumatoid Arthritis (RA) Flare
Time frame: End of Study (Week 104 or early withdrawal)
Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity
Time frame: Week 12 and Week 104
Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain
Time frame: Week 12 and Week 104
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: End of Study (Week 104 or early withdrawal)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) (time frame: End of Study (Week 104 or early withdrawal)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.