Assessment of safety, pharmacokinetics and efficacy in a combination treatment with SMP-114

A phase II, multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate disease modifying anti-rheumatic drug (DMARD) (SMP-114, 120 mg and 240 mg once daily) administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32398235

Enrollment

300

Registered

2006-02-23

Start date

2006-02-28

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis (RA) Musculoskeletal Diseases Other rheumatoid arthritis

Interventions

SMP-114 (120 mg and 240 mg) in combination with methotrexate compared to methotrexate alone.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged at least 18, with rheumatoid arthritis (RA) for a minimum of six months 2. Has been receiving methotrexate treatment (stable for eight weeks) 3. Has active disease classified as American College of Rheumatology (ACR) functional class of I, II or III

Exclusion criteria

Exclusion criteria: 1. Has previously discontinued DMARD therapy due to hepatic intolerance 2. Has received any DMARD in addition to methotrexate during the four weeks prior to randomisation 3. Is receiving more than two DMARDs in addition to methotrexate at the time of screening 4. Is receiving or has received gold, leflunomide or biological agents including tumour necrosis factor (TNF) or Interleukin 1 (IL-1) inhibitors within the eight weeks prior to randomisation 5. Has previously failed two or more DMARDS

Design outcomes

Primary

Measure	Time frame
The efficacy of SMP-114 (120 mg and 240 mg) versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at week 24.	—

Secondary

Measure	Time frame
1. The efficacy of SMP-114 (120 mg and 240 mg) versus placebo after 24 weeks in terms of: 1.1. ACR50 1.2. ACR70 1.3. Disease Activity Score-28 (DAS28) 1.4. European League Against Rheumatism (EULAR) response 2. The efficacy of SMP-114 versus placebo in terms of change in: 2.1. Core variables 2.2. Time to response 2.3. Quality of life 2.4. Radiological measurements of joint damage 2.5. Assessment of safety and tolerability 2.6. Pharmacokinetics (PK) measurements	—

Measure

Time frame

1. The efficacy of SMP-114 (120 mg and 240 mg) versus placebo after 24 weeks in terms of: 1.1. ACR50 1.2. ACR70 1.3. Disease Activity Score-28 (DAS28) 1.4. European League Against Rheumatism (EULAR) response 2. The efficacy of SMP-114 versus placebo in terms of change in: 2.1. Core variables 2.2. Time to response 2.3. Quality of life 2.4. Radiological measurements of joint damage 2.5. Assessment of safety and tolerability 2.6. Pharmacokinetics (PK) measurements

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Countries

Czech Republic, Germany, Hungary, Netherlands, Poland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026