Effect of anakinra (soluble interleukin-1 receptor antagonist) as combination therapy: second UK combination therapy in early rheumatoid arthritis

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN15819795
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

1. RA by the 1987 criteria of the American College of Rheumatology
2. Disease duration of less than 12 months
3. The clinical need for treatment with a Slow Acting Anti-Rheumatic Drug (SAARD) as shown by evidence of active RA with three out of the following four criteria:
3.1. At least three swollen joints on a 28 joint score
3.2. At least six tender joints on a 28 joint score
3.3. At least 45 minutes morning stiffness
3.4. Erythrocyte Sedimentation Rate (ESR) of at least 28 mm/h
4. Patients must be willing and able to give informed consent
5. Aged at least 18

Exclusion Criteria

1. Other forms of inflammatory arthritis (e.g. psoriatic arthritis, systemic lupus erythematosus)
2. Previous treatment with methotrexate
3. Contraindications or known intolerance to any of the drugs allowed on this trial (including Non Steroidal Anti-Inflammatory Drugs [NSAID], Steroids and Disease Modifying Anti-Rheumatic Drugs [DMARDs])
4. Other serious medical disorders (e.g. hepatic failure, gout, cardiac failure, tuberculosis, current malignant disease)
5. Any acute or chronic infection, including pneumonias
6. Females of child bearing and males of child fathering potential who are not taking adequate contraceptive protection
7. Neutrophil count less than 1.5 x 10^12/dl or platelet count less than 100 x 10^12/dl
8. Abnormal liver function test (gamma-Glutamyl Transferase [gGT] more than three times or Aspartate aminotransferase [AST]/Alanine aminotransferase [ALT] more than two times upper limit of normal)
9. Abnormal chest x-ray results
10. Patients with severe renal impairment (creatinine clearance less than 30 ml/min). Patients with a creatinine clearance between 30 and 50 ml/min can be entered into the trial but must be closely monitored
11. Patients taking low-dosage oral steroids for the treatment of RA. Patients taking a short-course of oral steroids for another condition may be included providing the daily dosage of steroids is less than 20 mg total

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the number and severity of joint erosions as measured with the van der Heijdi Modified Sharp score.

Secondary Outcome Measures

Name	Time	Method
1. Increases in the combined van der Heijde Modified Sharp score and in its three individual components<br>2. Decreases in disease activity measured by modified Disease Activity Score (DAS) and <br> American College of Rheumatology (ACR) response criteria<br>3. Changes in function measured by Health Assessment Questionnaire (HAQ)<br>4. Quality of life measured by Short Form health survey (SF-36) and EuroQol questionnaire <br>5. Health economics analysis measured by collection of standardised data set (used previously)