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

• ClinicalTrials.gov Identifier: NCT02010216
• Recruitment Status: Completed
• First Posted: December 12, 2013
• Results First Posted: September 25, 2014
• Last Update Posted: September 25, 2014
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis
• Study Start Date: March 2010
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: tocilizumab [RoActemra/Actemra]; Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).	Drug: tocilizumab [RoActemra/Actemra]; 8 mg/kg by intravenous infusion every 4 weeks; Other Name: RoActemra/Actemra

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Disease Activity 28 (DAS28) Score [ Time Frame: Baseline, Week 12 ]
   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.
2. Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved [ Time Frame: Baseline, Week 12 ]
   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].
3. Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Kazakhstan

Almaty, Kazakhstan, 050000

Astana, Kazakhstan, 010000

Astana, Kazakhstan, 010009

Shymkent, Kazakhstan, 160000

Shymkent, Kazakhstan, 160006

Ust-kamenogorsk, Kazakhstan, 070002

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02010216
• Other Study ID Numbers: ML23037
• First Posted: December 12, 2013
• Results First Posted: September 25, 2014
• Last Update Posted: September 25, 2014
• Last Verified: September 2014

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases