A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

NCT01063062 | Completed Phase 3 Results

• 1 other identifier: ML22725
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 9

Brief Summary

This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[RoActemra/Actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab \[RoActemra/Actemra\] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity

  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. Low Disease Activity was defined as a DAS28 score of \< 3.2.

  Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)

• Time to DAS28 Low Disease Activity

  Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score \<3.2 units. 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. Low Disease Activity was defined as a DAS28 score of \< 3.2.

  24 Weeks

Secondary Outcomes (15)

• Percentage of Participants Achieving DAS28 Clinically Significant Improvement

  Baseline, Weeks 4, 8, 12, 16, 20, 24

• Time to DAS28 Clinically Significant Improvement

  24 Weeks

• Percentage of Participants Achieving DAS28 Remission

  Weeks 4, 8, 12, 16, 20, 24

• Time to DAS28 Remission

  24 Weeks

• Disease Activity Score 28 (DAS28)

  Weeks 4, 8, 12, 16, 20, 24

Study Arms (1)

tocilizumab

EXPERIMENTAL

Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.

Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg intravenous infusion every 4 weeks.

tocilizumab

Methotrexate DRUG

methotrexate as per standard of care in clinical practice.

tocilizumab

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
• Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) \> 3.2 at screening)
• Patients with active RA after more than 12 weeks of treatment with DMARDs
• Patients with inadequate response to a stable dose of non-biologic DMARD

You may not qualify if:

• Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
• Prior history of or current inflammatory joint disease other than RA

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Alexandria University Hospital; Rheumatology

Alexandria, Egypt

Location

Alexandria University

Alexandria, Egypt

Location

Banha Educational Hospital; Rheumatology

Banhā, Egypt

Location

Kasr El Ainy Hospital; Rheumatology

Cairo, 11562, Egypt

Location

Ain Shams University Hospital; Rheumatology

Cairo, Egypt

Location

Bab El Sheereya Hospital; Rheumatology

Cairo, Egypt

Location

El Hussein University Hospital; Rheumatology

Cairo, Egypt

Location

Kasr El Ainy Hospital

Cairo, Egypt

Location

Manial Specialized Hospital; Rheumatology

Cairo, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: February 28, 2010
• Primary Completion: January 17, 2011
• Study Completion: January 17, 2011
• Last Updated: August 21, 2017
• Results First Posted: August 4, 2014

Record last verified: 2017-07

Locations

EG (9)