Phase 3
Completed N=71
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
Source: ClinicalTrials.gov NCT01235507 ↗Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) — 14.1; 2.8; 4.2 percentage of participants
Summary
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) |
14.1; 2.8; 4.2 | — |
| SECONDARY Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit |
6.28; 3.84; -2.44; 3.19; -3.09; 2.65 | <0.0005 sig |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 |
14.1; 31.0; 39.4; 49.3; 47.8; 71.0 | — |
| SECONDARY Swollen and Tender Joint Counts |
19.48; 6.72; -12.76; 3.73; -15.75; 2.43 | <0.0005 sig |
| SECONDARY Physician's Global Assessment of Disease Activity |
67.44; 35.99; -31.45; 26.48; -40.97; 19.28 | <0.0005 sig |
| SECONDARY Participant's Global Assessment of Disease Activity |
70; 42.87; -27.13; 33.20; -36.80; 24.56 | <0.0005 sig |
| SECONDARY Participant's Global Assessment of Pain |
69.73; 42.34; -27.39; 33.94; -35.79; 25.54 | <0.0005 sig |
| SECONDARY CRP Levels |
11.98; 5.11; -6.68; 3.84; -8.0; 5.53 | <0.0005 sig |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
36.13; 9.04; -27.09; 8.71; -27.42; 10.3 | <0.0005 sig |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis (RA)
- On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
- Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
- Body weight </= 150 kg
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
- Rheumatic autoimmune disease other than RA
- Functional class IV according to American College of Rheumatology (ACR) classification
- Prior history of or current inflammatory joint disease other then RA
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Treatment with any biologic drug that is used in the treatment or RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Positive for HIV
Data sourced from ClinicalTrials.gov (NCT01235507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.