SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00089921

Enrollment

302

Registered

2004-08-20

Start date

2004-07-31

Completion date

2005-10-31

Last updated

2010-10-18

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

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis, DMARDs, Methotrexate, p38 kinase

Brief summary

The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).

Detailed description

This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.

Interventions

DRUGSCIO-469

60 mg capsule three times daily for 12 weeks

DRUGPlacebo

2 capsules three times daily and one tablet daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs) * Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study

Exclusion criteria

* Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months * Lab tests revealed elevated liver enzymes within the past 6 months * Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy * HIV positive * Abnormal electrocardiogram * Chronic or acute infection

Design outcomes

Primary

Measure	Time frame
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)	Day 1 to approximately Day 85 of treatment

Secondary

Measure	Time frame
ACR50 responders at Week 12	12 weeks
ACR20 and ACR50 responders at each evaluation visit other than Week 12	24 weeks
All individual variables of the ACR response criteria at each evaluation visit	24 weeks
Disease Activity Score (DAS)28 at each evaluation visit.	24 Weeks
The number of participants experiencing adverse events (AEs) as a measure of safety	24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026