An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669902
• Other study ID #: ML28247
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: October 21, 2015
• Start date: April 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria

• Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included

• Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed

Exclusion Criteria:

• Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit

• Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use

• Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)

• Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment

• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants on Tocilizumab Treatment at Month 6		Month 6	No
Secondary	Percentage of Participants With Dose Modifications of Tocilizumab	Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.	Baseline to Month 6	No
Secondary	Swollen Joint Count (SJC)	Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.	Baseline, Month 3, Month 6	No
Secondary	Tender Joint Count (TJC)	Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.	Baseline, Month 3, Month 6	No
Secondary	Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])	DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)	DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.	Month 3 and Month 6	No
Secondary	Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.	Month 3 and Month 6	No
Secondary	Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)	The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.	Month 3 and Month 6	No
Secondary	Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)	The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.	Month 3 and Month 6	No
Secondary	Simplified Disease Activity Index (SDAI)	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and 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.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants Achieving Clinical Remission Based on SDAI	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and 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.	Month 3 and Month 6	No
Secondary	Clinical Disease Activity Index (CDAI)	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants Achieving Clinical Remission Based on CDAI	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.	Month 3 and Month 6	No
Secondary	Number of Participants With an American College of Rheumatology (ACR) Response	ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.	Baseline to Month 6	No
Secondary	Patient Global Assessment (PtGA) of Disease Activity Score	Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.	Baseline, Month 3, Month 6	No
Secondary	Physician Global Assessment (PGA) of Disease Activity	Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants in a PGA of Disease Activity Score Category	A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.	Baseline, Month 3, Month 6	No
Secondary	Patient Global Assessment of Pain	Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants With Morning Stiffness	The percentage of participants with morning stiffness ("yes", "no", or "do not know") was assessed at each visit.	Baseline, Month 3, Month 6	No
Secondary	Percentage of Participants With Duration of Morning Stiffness	Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.	Baseline, Month 3, Month 6	No
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item 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 and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Month 3 and Month 6	No
Secondary	Percentage of Participants With Concomitant Corticosteroids Treatment		Baseline to Month 6	No
Secondary	Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study		Baseline to Month 6	No