NCT01772316 - A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult participants, \>/= 18 years of age * Participants who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation * Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for \>/= 4 weeks prior to baseline * Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed * Receiving treatment on an outpatient basis * Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception Exclusion Criteria: * Participants who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason * Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies * History of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies * Evidence of serious uncontrolled concomitant disease * Current liver disease as determined by the principal investigator * History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations * Known active current or history of recurrent infections * Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening * Active tuberculosis requiring treatment within the previous 3 years * Primary or secondary immunodeficiency (history of or currently active) * Pregnant or breast feeding women * Body weight \> 150 kilogram (kg) * Inadequate renal, hepatic or hematologic function * Positive for hepatitis B or hepatitis C

Outcomes

Primary Outcomes

Percentage of Participants With an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a clinical investigation participant that was administered study drug, regardless of causal attribution.

Time frame: Baseline up to follow-up (Week 104)

Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response

Time frame: Baseline up to follow-up (Week 104)

Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included swollen joint count (SJC), tender joint count (TJC), acute phase response (ESR or high sensitivity C-reactive protein \[hsCRP\]) and general health status (GH). For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √\[TJC 28\]) + (0.28 × √\[SJC 28\]) + (0.7 × ln\[ESR\]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 48 - DAS28-ESR at Baseline.

Time frame: Baseline, Week 48

Change From Baseline in DAS28-ESR at Week 96

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included SJC, TJC, acute phase response (ESR or high sensitivity C-reactive protein \[hsCRP\]) and general health status. For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √\[TJC28\]) + (0.28 × √\[SJC28\]) + (0.7 × ln\[ESR\]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 96 - DAS28-ESR at Baseline.

Time frame: Baseline, Week 96

Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48

The SDAI was the numerical sum of five outcome parameter: SJC and TJC, Patient Global Assessment of Disease Activity (PGA) and Investigator Global Assessment of Disease Activity (IGA), and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 48 - SDAI at Baseline. 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. Here, n signifies the number of subjects evaluable at the specified time points.

Time frame: Baseline, Week 48

Change From Baseline in SDAI at Week 96

The SDAI was the numerical sum of five outcome parameter: SJC and TJC, PGA and IGA, and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 96 - SDAI at Baseline. 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: Baseline, Week 96

Change From Baseline in Total Tender Joint Count (TJC) at Week 48

An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement. Here, 'n' represents the number of participants with a measure at specified time point.

Time frame: Baseline, Week 48

Change From Baseline in Total TJC at Week 96

Time frame: Baseline, Week 96

Change From Baseline in Swollen Joint Count (SJC) at Week 48

Time frame: Baseline, Week 48

Change From Baseline in SJC at Week 96

An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. Change in SJC = SJC at Week 96 - SJC at Baseline. A negative number indicated improvement.

Time frame: Baseline, Week 96

Secondary Outcomes

Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96

Time frame: Week 48, Week 96

Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation

Time frame: Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)

Patient Global Visual Analog Score (VAS) at Specified Time Points

This assessment represents the patient's overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS. The extreme left end of the line should be described as "no disease activity" (symptom free and no arthritis symptoms) and the extreme right end as "maximum disease activity" (maximum arthritis disease activity). Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.

Time frame: Baseline, Week 48, Week 96

Patient Pain VAS Score at Specified Time Points

This assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as "no pain" and the extreme right end as "unbearable pain". Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.

Time frame: Baseline, Week 48, Week 96

Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points

The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Minimum score was 0, maximum score was 3. A smaller score indicated improvement.

Time frame: Baseline, Week 48, Week 96

A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes