---
title: Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
nct_id: NCT00256919
overall_status: COMPLETED
phase: PHASE2
sponsor: GlaxoSmithKline
study_type: INTERVENTIONAL
primary_condition: Arthritis, Rheumatoid
countries: Bulgaria, Germany, Spain, Sweden, Ukraine
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00256919.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00256919"
ct_last_update_post_date: 2012-11-05
last_seen_at: "2026-05-12T07:17:12.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

**Official Title:** A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship

**NCT ID:** [NCT00256919](https://clinicaltrials.gov/study/NCT00256919)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 51
- **Lead Sponsor:** GlaxoSmithKline
- **Conditions:** Arthritis, Rheumatoid
- **Start Date:** 2005-11
- **Completion Date:** 2006-11
- **CT.gov Last Update:** 2012-11-05

## Brief Summary

This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion criteria:

* Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
* Must have 3 or more swollen or 3 or more tender/painful joints at screening.
* Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening.

Exclusion criteria:

* Must not be morbidly obese.
```

## Interventions

- **GW856553** (DRUG)

## Primary Outcomes

- **C-reactive protein (CRP) levels 72 hours post-dose.** _(time frame: 72 hours post-dose.)_

## Secondary Outcomes

- **C-reactive protein (CRP) levels 24 and 48 hours post-dose** _(time frame: 24 and 48 hours post-dose)_

## Locations (17)

- GSK Investigational Site, Plovdiv, Bulgaria
- GSK Investigational Site, Sofia, Bulgaria
- GSK Investigational Site, Sofia, Bulgaria
- GSK Investigational Site, Erlangen, Bavaria, Germany
- GSK Investigational Site, Munich, Bavaria, Germany
- GSK Investigational Site, Hamburg, Free and Hanseatic City of Hamburg, Germany
- GSK Investigational Site, Bad Bramstedt, Schleswig-Holstein, Germany
- GSK Investigational Site, Madrid, Spain
- GSK Investigational Site, Santiago de Compostela, Spain
- GSK Investigational Site, Seville, Spain
- GSK Investigational Site, Linköping, Sweden
- GSK Investigational Site, Uppsala, Sweden
- GSK Investigational Site, Donetsk, Ukraine
- GSK Investigational Site, Kharkiv, Ukraine
- GSK Investigational Site, Kiev, Ukraine
- GSK Investigational Site, Kyiv, Ukraine
- GSK Investigational Site, Lviv, Ukraine

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gsk investigational site|plovdiv||bulgaria` — added _(2026-05-12)_
- `locations.gsk investigational site|sofia||bulgaria` — added _(2026-05-12)_
- `locations.gsk investigational site|erlangen|bavaria|germany` — added _(2026-05-12)_
- `locations.gsk investigational site|munich|bavaria|germany` — added _(2026-05-12)_
- `locations.gsk investigational site|hamburg|free and hanseatic city of hamburg|germany` — added _(2026-05-12)_
- `locations.gsk investigational site|bad bramstedt|schleswig-holstein|germany` — added _(2026-05-12)_
- `locations.gsk investigational site|madrid||spain` — added _(2026-05-12)_
- `locations.gsk investigational site|santiago de compostela||spain` — added _(2026-05-12)_
- `locations.gsk investigational site|seville||spain` — added _(2026-05-12)_
- `locations.gsk investigational site|linköping||sweden` — added _(2026-05-12)_
- `locations.gsk investigational site|uppsala||sweden` — added _(2026-05-12)_
- `locations.gsk investigational site|donetsk||ukraine` — added _(2026-05-12)_
- `locations.gsk investigational site|kharkiv||ukraine` — added _(2026-05-12)_
- `locations.gsk investigational site|kiev||ukraine` — added _(2026-05-12)_
- `locations.gsk investigational site|kyiv||ukraine` — added _(2026-05-12)_
- `locations.gsk investigational site|lviv||ukraine` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00256919.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00256919*  
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