---
title: A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
nct_id: NCT01208181
overall_status: COMPLETED
phase: PHASE3
sponsor: Organon and Co
study_type: INTERVENTIONAL
primary_condition: Arthritis, Rheumatoid
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01208181.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01208181"
ct_last_update_post_date: 2024-06-18
last_seen_at: "2026-05-12T07:16:34.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

**Official Title:** A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis

**NCT ID:** [NCT01208181](https://clinicaltrials.gov/study/NCT01208181)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1404
- **Lead Sponsor:** Organon and Co
- **Conditions:** Arthritis, Rheumatoid
- **Start Date:** 2010-09-27
- **Completion Date:** 2014-07-29
- **CT.gov Last Update:** 2024-06-18

## Brief Summary

This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.

## Eligibility

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

```
Inclusion Criteria:

* Is male or female ≥ 18 years of age in general good health (other than RA)
* Has an American College of Rheumatology Rheumatoid Clinical Response Criteria (ACR) Functional Class I, II, or III
* Has a diagnosis of RA at least 6 months ago and was at least 16 years of age when diagnosed
* Has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (NSAIDs) and is taking an NSAID on a regular basis and at a therapeutic dose level and is not anticipated to undergo a change during the study

Exclusion Criteria:

* Has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
* Has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption
* Has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
* Has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease
* Class II-IV congestive heart failure
* Has uncontrolled hypertension (systolic \>160 mm Hg or diastolic \> 90 mm Hg) at Visit 1 or Visit 2
* Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥5
* Has estimated glomerular filtration rate ≤30 mL/min
* Has a history of neoplastic disease within 5 years (exceptions: basal cell carcinoma or carcinoma in situ of the cervix)
* Is allergic to etoricoxib; history of a significant clinical or laboratory adverse experience associated with etoricoxib; hypersensitivity to aspirin or NSAIDs; or allergy to acetaminophen/paracetamol
* Has a personal or family history of an inherited or acquired bleeding disorder
* Requires oral corticosteroid therapy in excess of the equivalent of 10 mg daily of prednisone and/or have not been on a stable dose for at least 4 weeks prior to Visit 1 and/or whose dose is not expected to remain stable during the study
* Treated with B-cell depleting therapies within the past 6 months or anticipate this treatment during this trial
* Is a recreational or illicit drug use, or history within 5 years of drug or alcohol abuse/dependence;
* Is morbidly obese (defined as body mass index ≥40 kg/m\^2)
* Is pregnant or breast feeding
```

## Arms

- **Etoricoxib 60 mg/Etoricoxib 60 mg** (EXPERIMENTAL) — The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and Part 2 of the study.
- **Etoricoxib 60 mg/Etoricoxib 90 mg** (EXPERIMENTAL) — The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 2 of the study.
- **Etoricoxib 90 mg** (EXPERIMENTAL) — The etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.
- **Placebo** (PLACEBO_COMPARATOR) — The placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.

## Interventions

- **Etoricoxib 60 mg** (DRUG) — One tablet orally once daily for 6 weeks.
- **Etoricoxib 90 mg** (DRUG) — One tablet orally once daily for 6 weeks.
- **Placebo to Etoricoxib 60 mg** (DRUG) — One tablet orally once daily for 6 weeks.
- **Placebo to Etoricoxib 90 mg** (DRUG) — One tablet orally once daily for 6 weeks

## Primary Outcomes

- **Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)** _(time frame: Baseline and Week 6)_ — Disease Activity Score Using C-Reactive Protein \[DAS28-CRP\] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56\*square root (sqrt) (tender joint count \[28\])+0.28\*sqrt(swollen joint count \[28\] )+0.36\* ln(crp+1) + 0.014\* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
- **Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)** _(time frame: Baseline and Week 6)_ — A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
- **Percentage of Participants Who Experienced at Least One Adverse Event (AE)** _(time frame: Up to 112 days)_ — An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
- **Percentage of Participants Who Discontinued Study Drug Due to an AE** _(time frame: Up to Week 12)_ — An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

## Secondary Outcomes

- **Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)** _(time frame: Baseline and Week 6)_
- **Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)** _(time frame: Baseline and Week 6)_
- **Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1** _(time frame: Week 6 and Week 10 to Week 12)_

## 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.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01208181.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01208181*  
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