A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)

NCT02010216 | Completed Phase 4 Results

• 1 other identifier: ML23037
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

Brief Summary

This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Disease Activity 28 (DAS28) Score

  The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.

  Baseline, Week 12

• Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved

  American College of Rheumatology (ACR) ACR20, ACR50 or ACR70 response is defined as a ≥ 20% or 50% or 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].

  Baseline, Week 12

• Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  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. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution 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.

  12 weeks

Study Arms (1)

tocilizumab [RoActemra/Actemra]

EXPERIMENTAL

Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg by intravenous infusion every 4 weeks

Also known as: RoActemra/Actemra

tocilizumab [RoActemra/Actemra]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, ≥ 18 years of age
• Confirmed moderate or severe rheumatoid arthritis
• Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)

You may not qualify if:

• Presence of infectious diseases \[tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C\]
• Inadequate hematologic, renal or liver function
• Peptic ulcer disease (in acute phase)
• Pregnant and lactating women

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Almaty, 050000, Kazakhstan

Location

Unknown Facility

Astana, 010000, Kazakhstan

Location

Unknown Facility

Astana, 010009, Kazakhstan

Location

Unknown Facility

Shymkent, 160000, Kazakhstan

Location

Unknown Facility

Shymkent, 160006, Kazakhstan

Location

Unknown Facility

Ust-Kamenogorsk, 070002, Kazakhstan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 12, 2013
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

KA (6)