Rheumatoid ArthritisPhase 2NCT00903383

Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate

A Phase 2 study testing LX3305 low dose, LX3305 mid dose and LX3305 high dose in people with Rheumatoid Arthritis, run by Lexicon Pharmaceuticals at 38 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: LX3305 low dose, LX3305 mid dose and LX3305 high dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 208 participants
Where: 38 sitesin 6 countries
Study dates: Jul 2009to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females aged 18-75 years old
Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level > upper limit of normal
Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
Ability to provide written informed consent

Who cannot join

RA diagnosis prior to 16 years of age (Juvenile RA)
Lack of response to >3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to >1 biologic DMARD
Use of DMARDs other than MTX within 12 weeks prior to Day 1
Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
Blood donation or receipt of live vaccine within 4 weeks prior to Day 1
Major surgical procedure within 8 weeks prior to Day 1

Show all 11Show fewer

Any systemic inflammatory condition, recurrent infection, or current infection other than onychomycosis
History of cancer within 5 years prior to Day 1
Presence of hepatic or biliary disease
History of tuberculosis
History of human immunodeficiency virus (HIV)

Trial locations and contacts

38 sites in 6 countries.

Country

City, postcode or hospital

38 sites in 6 countries

United States13 sites

Lexicon Investigational Site
Cumberland, Maryland, 21502
Lexicon Investigational Site
Dallas, Texas, 75235
Lexicon Investigational Site
Flowood, Mississippi, 39232
Lexicon Investigational Site
Gainesville, Florida, 32607
Lexicon Investigational Site
Hagerstown, Maryland, 21740
Lexicon Investigational Site
Hickory, North Carolina, 28601
Lexicon Investigational Site
Kalamazoo, Michigan, 49009
Lexicon Investigational Site
La Crosse, Wisconsin, 54601
Lexicon Investigational Site
Nashville, Tennessee, 37205
Lexicon Investigational Site
Orange Park, Florida, 32073
Lexicon Investigational Site
Orlando, Florida, 32804
Lexicon Investigational Site
Philadelphia, Pennsylvania, 19152
Lexicon Investigational Site
Tampa, Florida, 33614

Other trials in United States

Poland8 sites

Lexicon Investigational Site
Bialystok
Lexicon Investigational Site
Działdowo
Lexicon Investigational Site
Gdynia
Lexicon Investigational Site
Katowice
Lexicon Investigational Site
Lublin
Lexicon Investigational Site
Warsaw
Lexicon Investigational Site
Włoszczowa
Lexicon Investigational Site
Wroclaw

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Hungary6 sites

Lexicon Investigational Site
Békéscsaba
Lexicon Investigational Site
Budapest
Lexicon Investigational Site
Kecskemét
Lexicon Investigational Site
Makó
Lexicon Investigational Site
Sopron
Lexicon Investigational Site
Veszprém

Other trials in Hungary

Bulgaria5 sites

Lexicon Investigational Site
Pleven
Lexicon Investigational Site
Plovdiv
Lexicon Investigational Site
Rousse
Lexicon Investigational Site
Sofia
Lexicon Investigational Site
Veliko Tarnovo

Other trials in Bulgaria

Czechia4 sites

Lexicon Investigational Site
Bruntál
Lexicon Investigational Site
Hlučín
Lexicon Investigational Site
Sokolov
Lexicon Investigational Site
Zlín

Other trials in Czechia

Serbia2 sites

Lexicon Investigational Site
Belgrade
Lexicon Investigational Site
Niška Banja

Other trials in Serbia

About this study

Official title: A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.

Conditions: Rheumatoid Arthritis
Being tested: LX3305 low dose, LX3305 mid dose, LX3305 high dose, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LX3305 low doseDrug
A low dose of LX3305; daily oral intake for 12 weeks
LX3305 mid doseDrug
A mid dose of LX3305; daily oral intake for 12 weeks
LX3305 high doseDrug
A high dose of LX3305; daily oral intake for 12 weeks
PlaceboDrug
Matching placebo dosing with daily oral intake for 12 weeks

Study groups in NCT00903383
Study group	Role	What they receive
Low Dose	Experimental	A low dose of LX3305; daily oral intake for 12 weeks Receives: Drug: LX3305 low dose
Mid Dose	Experimental	A mid dose of LX3305; daily oral intake for 12 weeks Receives: Drug: LX3305 mid dose
High Dose	Experimental	A high dose of LX3305; daily oral intake for 12 weeks Receives: Drug: LX3305 high dose
Placebo	Placebo comparator	Matching placebo dosing with daily oral intake for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

ACR20 Response at Week 12
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
Measured: Baseline and 12 weeks

Secondary outcomes (5)

ACR50 Response at Week 12
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 50% response criteria (ACR50) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR50, there had to be ≥50% improvement in swollen joint count, ≥50% improvement in painful/tender joint count, and ≥50% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
Measured: Baseline and 12 weeks
ACR70 Response at Week 12
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 70% response criteria (ACR70) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR70, there had to be ≥70% improvement in swollen joint count, ≥70% improvement in painful/tender joint count, and ≥70% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
Measured: Baseline and 12 weeks
Hybrid ACR Response at Week 12
Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. The percentage improvement from baseline was computed in each of the components of the ACR. The average percent improvement was calculated and used with the subject's ACR20, ACR50, and ACR70 status to compute the hybrid ACR response, with a positive change indicating improvement.
Measured: Baseline and 12 weeks
Change From Baseline in C-reactive Protein (mg/L) at Week 12
The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.
Measured: Baseline and 12 weeks
Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12
The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Sep 2010

First posted18 May 2009 (estimated)
Study startJul 2009
Primary completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00903383
Sponsor's protocol ID: Protocol LX3305.1-201-RA
Other IDs: LX3305.201, LX2931
Status last verified: Nov 2011
First submitted: 14 May 2009
Last updated: 15 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy
ClinicalTrials.gov ID: NCT00903383
Acronym / sponsor ID: Protocol LX3305.1-201-RA
Conditions: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Sep 2010 (actual)
First posted: 18 May 2009 (estimated)
Results: Posted 15 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Low Dose	Experimental	Drug: LX3305 low doseA low dose of LX3305; daily oral intake for 12 weeks
Mid Dose	Experimental	Drug: LX3305 mid doseA mid dose of LX3305; daily oral intake for 12 weeks
High Dose	Experimental	Drug: LX3305 high doseA high dose of LX3305; daily oral intake for 12 weeks
Placebo	Placebo comparator	Drug: PlaceboMatching placebo dosing with daily oral intake for 12 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females aged 18-75 years old
Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level > upper limit of normal
Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
Ability to provide written informed consent

Key exclusion criteria (11 listed)

RA diagnosis prior to 16 years of age (Juvenile RA)
Lack of response to >3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to >1 biologic DMARD
Use of DMARDs other than MTX within 12 weeks prior to Day 1
Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
Blood donation or receipt of live vaccine within 4 weeks prior to Day 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LX3305 low doseA low dose of LX3305; daily oral intake for 12 weeks	Drug	Low Dose
LX3305 mid doseA mid dose of LX3305; daily oral intake for 12 weeks	Drug	Mid Dose
LX3305 high doseA high dose of LX3305; daily oral intake for 12 weeks	Drug	High Dose
PlaceboMatching placebo dosing with daily oral intake for 12 weeks	Drug	Placebo

Primary outcome

ACR20 Response at Week 12
Time frame: Baseline and 12 weeks
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).

5 secondary outcomes

ACR50 Response at Week 12
Time frame: Baseline and 12 weeks
ACR70 Response at Week 12
Time frame: Baseline and 12 weeks
Hybrid ACR Response at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in C-reactive Protein (mg/L) at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 15 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose	55	48
Mid Dose	54	48
High Dose	50	47
Placebo	49	44

Primary outcome: ACR20 Response at Week 12

Time frame: Baseline and 12 weeks. Number. Unit: Participants

Measure	Low Dose n = 55	Mid Dose n = 54	High Dose n = 50	Placebo n = 49
Value	24	22	30	24

Population analysed: Intent to Treat Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were followed during the 12-week Treatment period and during the 30-day Follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose	2 of 55 (3.6%)	10 of 55 (18.2%)	Not reported
Mid Dose	0 of 54 (0%)	5 of 54 (9.3%)	Not reported
High Dose	0 of 50 (0%)	10 of 50 (20%)	Not reported
Placebo	0 of 49 (0%)	12 of 49 (24.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel P. Freiman, MD, MPH study director

Lexicon Pharmaceuticals, Inc.

38 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LX3305 low dose, LX3305 mid dose and LX3305 high dose in people with Rheumatoid Arthritis, run by Lexicon Pharmaceuticals at 38 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Poland, Hungary, Bulgaria, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20 Response at Week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00903383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.