A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

Rheumatoid Arthritis Clinical Trial

Official title:

Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705730
• Other study ID #: ML28269
• Status: Completed
• Start date: July 31, 2012
• Est. completion date: December 12, 2014

Study information

• Verified date: August 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 12, 2014
• Est. primary completion date: December 12, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants, >/= 18 years of age

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

• Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

• Concomitant treatment with NSAIDs and/or corticosteroids is allowed

Exclusion Criteria:

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

• Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use

• Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study

• Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

• Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	CH EpiCURA Site Ath	Ath
Belgium	CHU Brugmann (Victor Horta)	Bruxelles
Belgium	Hospital Erasme; Neurologie	Bruxelles
Belgium	Reumaclinic	Genk
Belgium	GHdC Site Saint-Joseph	Gilly (Charleroi)
Belgium	Clinique Notre Dame de Grâce	Gosselies
Belgium	CH Jolimont - Lobbes (Jolimont)	Haine-Saint-Paul
Belgium	AZ Groeninge	Kortrijk
Belgium	Chr de La Citadelle	Liège
Belgium	Clinique Saint-Joseph	Liège
Belgium	CHU Ambroise Paré	Mons
Belgium	AZ Damiaan	Oostende
Belgium	Clinique St Pierre asbl	Ottignies
Belgium	AZ Delta (Campus Wilgenstraat)	Roeselare
Belgium	AZ Turnhout Sint Jozef	Turnhout
Belgium	Sint Augustinus Wilrijk	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation		Month 6 after treatment initiation
Secondary	Percentage of Participants With Systemic Manifestations of RA at Baseline	Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.	Baseline
Secondary	Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response		Baseline
Secondary	Number of Participants With Inadequate Response to Other Biologics		Baseline
Secondary	Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)	The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.	Month 6
Secondary	Percentage of Participants Who Had DMARDs During Study		Month 6
Secondary	Number of Participants With Dose Reductions		6 months
Secondary	Number of Participants With Starting Tocilizumab After Failing DMARDs		Baseline
Secondary	Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents		Baseline
Secondary	Time to Reduction/Withdrawal of Corticosteroids		Month 6
Secondary	Number of Dose Modifications Per Participant at Month 6	Number of dose modification per participant at Month 6 was reported.	Month 6
Secondary	Mean Dosing Interval Per Participant at Month 6		Month 6
Secondary	Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy		Month 6
Secondary	Time for Restoration of Initial Dosing Regimen		Month 6
Secondary	Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen		Month 6
Secondary	Number of Participants Who Were Not Adhering to Recommended Management of AEs		Month 6
Secondary	Percentage of Participants Still on Tocilizumab Monotherapy at Month 6		Month 6
Secondary	Percentage of Participants With Reason for Choice of Monotherapy at Baseline		Baseline
Secondary	Tender Joint Count (TJC)	TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.	Baseline, Month 3, 6
Secondary	Swollen Joint Count (SJC)	SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.	Baseline, Month 3, 6
Secondary	Percentage of Participants With Disease Activity Score-28 (DAS28)	DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.	Baseline, Month 3, 6
Secondary	Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to = 5.1 or a CFB < -0.6 to = -1.2. EULAR No response: DAS28 =3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement.	Month 3, 6
Secondary	Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6	ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.	Month 3, 6
Secondary	Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response	CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) 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, 6
Secondary	Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response	The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score	Baseline, Month 3, 6
Secondary	Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6	The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.	Baseline, Month 3, 6
Secondary	Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6	The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.	Baseline, Month 3, 6
Secondary	Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6	The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.	Baseline, Month 3, 6
Secondary	Change From Baseline in VAS-Fatigue at Month 3 and Month 6	The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.	Baseline, Month 3, 6
Secondary	Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6	The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.	Baseline, Month 3, 6
Secondary	Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6	Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.	Baseline, Month 3, 6
Secondary	Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), 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. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.	Month 6
Secondary	Percentage of Participants With AEs Leading to Dose Modifications		Month 6
Secondary	C-reactive Protein (CRP]) Level	CRP is an acute phase reactant and is a measure of inflammation.	Baseline, Month 3, 6
Secondary	Erythrocyte Sedimentation Rate (ESR) Level	ESR is an acute phase reactant and is a measure of inflammation.	Baseline, Month 3, 6