A Phase 3 interventional study of Tocilizumab in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 12 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 49 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Tocilizumab
8 mg/kg administered intravenously (IV) every 4 weeks for 104 weeks
Also known as: RoActemra, Actemra
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)
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.
Time frame: Up to 112 weeks
Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE.
Time frame: Up to 112 weeks
Percentage of Adverse Events With Severity as Mild, Moderate, and Severe
Time frame: Up to 112 weeks
Percent Change From Baseline in the Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Over Time
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.
Time frame: 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
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.
Time frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Change From Baseline in Tender Joint Count 66 (TJC 66) Over Time
Number of tender joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.
Time frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Change From Baseline in Swollen Joint Count 66 (SJC 66) Over Time
Number of swollen joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.
Time frame: 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
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.
Time frame: Up to 104 weeks
Time to Rheumatoid Arthritis Recurrence in Participants Who Achieved Treatment-Free Remission
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.
Time frame: Up to 104 weeks
Percent Change in Participant's General Assessment of Disease Activity (Severity of Disease) VAS Over Time
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.
Time frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Percent Change in Participant's Assessment of Pain (VAS) Over Time
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.
Time frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Change From Baseline in Health Assessment Questionnaire (HAQ-DI) Score Over Time
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.
Time frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
| Milestone | Tocilizumab |
|---|---|
| Started | 49 |
| Completed | 43 |
| Not completed | 6 |
| Withdrew: Sponsor decision | 1 |
| Withdrew: Withdrawal of informed consent | 4 |
| Withdrew: Adverse event | 1 |
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.
| percentage of participants | Tocilizumab |
|---|---|
| Adverse Events | 69.4 |
| SAEs | 10.2 |
| AESIs | 17.2 |
An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE.
| percentage of adverse events | Tocilizumab |
|---|---|
| AEs Leading to Dose Modification | 34.5 |
| AEs Leading to Study Withdrawal | 1.1 |
| percentage of adverse events | Tocilizumab |
|---|---|
| Mild | 62.1 |
| Moderate | 36.8 |
| Severe | 1.1 |
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.
| percent change | Tocilizumab |
|---|---|
| Change at Week 12 (n=42) | -35.4 ± 30.4 |
| Change at Week 24 (n=40) | -27.2 ± 35.4 |
| Change at Week 36 (n=39) | -29.3 ± 48.4 |
| Change at Week 48 (n=33) | -24.6 ± 41.0 |
| Change at Week 56 (n=34) | -32.5 ± 31.9 |
| Change at Week 68 (n=32) | -38.3 ± 25.6 |
| Change at Week 80 (n=28) | -29.4 ± 33.5 |
| Change at Week 92 (n=22) | -26.9 ± 30.9 |
| Change at Week 104 (n=26) | -38.1 ± 25.9 |
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.
| percent change | Tocilizumab |
|---|---|
| Change at Week 12 (n=37) | -45.5 ± 33.9 |
| Change at Week 24 (n=36) | -34.7 ± 45.6 |
| Change at Week 36 (n=38) | -6.3 ± 221.1 |
| Change at Week 48 (n=36) | -12.4 ± 84.3 |
| Change at Week 56 (n=34) | -39.3 ± 66.4 |
| Change at Week 68 (n=35) | -47.3 ± 39.6 |
| Change at Week 80 (n=36) | -30.3 ± 66.9 |
| Change at Week 92 (n=36) | -12.5 ± 140.1 |
| Change at Week 104 (n=35) | -28.8 ± 115.7 |
Number of tender joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.
| tender joints | Tocilizumab |
|---|---|
| Change at Week 12 (n=49) | -5.0 ± 6.7 |
| Change at Week 24 (n=47) | -5.7 ± 9.5 |
| Change at Week 36 (n=47) | -6.6 ± 10.4 |
| Change at Week 48 (n=46) | -6.2 ± 11.8 |
| Change at Week 56 (n=44) | -6.7 ± 10.6 |
| Change at Week 68 (n=45) | -6.6 ± 10.6 |
| Change at Week 80 (n=45) | -6.2 ± 10.8 |
| Change at Week 92 (n=43) | -6.3 ± 11.9 |
| Change at Week 104 (n=43) | -7.4 ± 10.9 |
Number of swollen joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.
| swollen joints | Tocilizumab |
|---|---|
| Change at Week 12 (n=49) | -3.5 ± 7.9 |
| Change at Week 24 (n=47) | -3.7 ± 8.2 |
| Change at Week 36 (n=47) | -4.5 ± 9.9 |
| Change at Week 48 (n=46) | -4.6 ± 9.9 |
| Change at Week 56 (n=44) | -4.7 ± 9.7 |
| Change at Week 68 (n=45) | -4.9 ± 9.7 |
| Change at Week 80 (n=45) | -4.6 ± 9.7 |
| Change at Week 92 (n=43) | -4.3 ± 10.2 |
| Change at Week 104 (n=43) | -5.0 ± 10.0 |
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.
| percentage of participants | Tocilizumab |
|---|---|
| Percentage of Participants With Treatment-Free Remission According to DAS28-ESR/SDAI Remission Criteria | 71.4 |
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.
| weeks | Tocilizumab |
|---|---|
| Time to Rheumatoid Arthritis Recurrence in Participants Who Achieved Treatment-Free Remission | 23 (17.6 to 28.4) |
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.
| percent change | Tocilizumab |
|---|---|
| Change at Week 12 (n=48) | -19.6 ± 45.7 |
| Change at Week 24 (n=46) | -20.3 ± 49.8 |
| Change at Week 36 (n=46) | -17.5 ± 60.6 |
| Change at Week 48 (n=45) | 6.1 ± 92.8 |
| Change at Week 56 (n=43) | -14.2 ± 63.8 |
| Change at Week 68 (n=44) | -19.3 ± 48.6 |
| Change at Week 80 (n=44) | -9.2 ± 58.1 |
| Change at Week 92 (n=43) | -4.7 ± 67.2 |
| Change at Week 104 (n=42) | -14.2 ± 75.7 |
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.
| percent change | Tocilizumab |
|---|---|
| Change at Week 12 (n=48) | -21.8 ± 43.2 |
| Change at Week 24 (n=46) | -20.3 ± 44.9 |
| Change at Week 36 (n=46) | -25.4 ± 50.0 |
| Change at Week 48 (n=45) | 4 ± 131.4 |
| Change at Week 56 (n=43) | -19.8 ± 66.3 |
| Change at Week 68 (n=44) | -19.9 ± 57.6 |
| Change at Week 80 (n=44) | -17.1 ± 54.2 |
| Change at Week 92 (n=43) | -10.9 ± 59.2 |
| Change at Week 104 (n=42) | -20.5 ± 61.3 |
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.
| score on a scale | Tocilizumab |
|---|---|
| Change at Week 12 (n=49) | -0.2 ± 0.4 |
| Change at Week 24 (n=46) | -0.2 ± 0.4 |
| Change at Week 36 (n=46) | -0.1 ± 0.4 |
| Change at Week 48 (n=45) | 0.0 ± 0.5 |
| Change at Week 56 (n=44) | -0.1 ± 0.6 |
| Change at Week 68 (n=45) | -0.2 ± 0.5 |
| Change at Week 80 (n=45) | -0.2 ± 0.5 |
| Change at Week 92 (n=43) | 0.0 ± 0.6 |
| Change at Week 104 (n=43) | -0.1 ± 0.5 |
Collected over Up to 112 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tocilizumab | 0/49 (0%) | 5/49 (10.2%) | 22/49 (44.9%) |
| Event | Tocilizumab |
|---|---|
| ArrhythmiaCardiac disorders | 1/49 |
| HypertensionVascular disorders | 1/49 |
| Cholecystitis acuteHepatobiliary disorders | 1/49 |
| Hypertensive crisisVascular disorders | 1/49 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/49 |
| Jaw abscessMusculoskeletal and connective tissue disorders | 1/49 |
| Event | Tocilizumab |
|---|---|
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 9/49 |
| Alanine aminotransferase increasedInvestigations | 5/49 |
| BronchitisInfections and infestations | 4/49 |
| Aspartate aminotransferase increasedInvestigations | 3/49 |
| DyslipidaemiaMetabolism and nutrition disorders | 3/49 |
| NeutropeniaBlood and lymphatic system disorders | 3/49 |
Full analysis set (FAS), includes all randomized participants enrolled in the study who received at least one dose of tocilizumab.
| Age, Continuous(years) | Tocilizumab |
|---|---|
| Mean | 53.3 ± 10.8 |
| Sex: Female, Male(Participants) | Tocilizumab |
|---|---|
| Female | 36 |
| Male | 13 |
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche