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Rheumatoid ArthritisPhase 2MOTIONNCT01116141

A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

A Phase 2 study testing CH-4051, Methotrexate (MTX) and Folic Acid in people with Rheumatoid Arthritis, run by Chelsea Therapeutics.

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 this study is to determine if CH-4051 is a safe and effective treatment for rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
CH-4051, Methotrexate (MTX) and Folic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
No sites listed yet
Study dates
Sep 2010to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be between the ages of 18 and 80;
  • Have diagnosed active rheumatoid arthritis according to ACR criteria functional class I-III;
  • Have at least 6 swollen joints (max = 66) and 6 tender joints (max = 68) at screening and baseline visits;
  • Patients must have at least one of the following:
  • C-reactive protein > 1.0 mg/dl at screening;
  • erythrocyte sedimentation rate > 28 mm/Hr;
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  • Patients must have been taking methotrexate between 15 and 25 mg/week for at least 3 months and at a stable dose for at least 6 weeks;
  • Patients must be either Rheumatoid Factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positive;
  • Patients must have voluntarily signed the informed consent.

Who cannot join

  • Patients who received previous therapy with any biologic agent;
  • Patients currently taking any disease modifying anti-rheumatic drug (DMARD) other than MTX;
  • Previous non-biologic DMARD therapy is permitted as long as their last dose was at least 30 days prior to baseline;
  • Female patients of child bearing potential who are pregnant or who are not using two methods of contraception (at least one barrier: i.e. condom) with their partner;
  • Male patients who are sexually active and not using two methods of contraception (at least one barrier: i.e. condom) with their partner;
  • Patients with any current active infection or infections requiring IV drug therapy within 30 days of baseline or oral therapy within 15 days of Baseline;
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  • Patients that have had any surgical procedures within 30 days of baseline;
  • Patients with a history of HIV;
  • Patients with Hepatitis B surface antigen positive and/or Hepatitis C antibody positive;
  • Patients who consume more than 4 units of alcohol per week (1 unit = 5 ounces/150 ml of wine = 1.5 ounces/45 ml spirits = 12 ounces/360 ml of beer);
  • Patients currently receiving any investigational drug or have received an investigational drug within 30 days of baseline or 5 half-lives of the investigational drug (whichever is longer);
  • Patients with a history of cancer within the past 5 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ;
  • Patients with a history of, or any, disease associated with an inflammatory arthritis other than RA;
  • Patients with pulmonary fibrosis (Chest x-ray must be taken within 28 days of screening);
  • Patients receiving probenecid;
  • Patients who have received any steroid injections within 30 days of baseline;
  • Patients with concomitant diseases that are unstable (i.e. cardiac, pulmonary) or that may affect drug activity (i.e. absorption, reactions, change in kinetics);
  • Patients, in the investigator's opinion, that have any significant renal or hepatic impairment;
  • Patients with a serum creatinine level > 1.5 mg/dl at screening;
  • Patients with an ALT >1.5 ULN at screening;
  • Patients considered by the investigator to be an unsuitable candidate to receive CH-4051;
  • Wheelchair or bed-bound patients.

About this study

Official title: A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy

The purpose of this study is to determine if CH-4051 is a safe and effective treatment for rheumatoid arthritis.

Read the detailed description

Multi-center, multi-national, double-blind, randomized, active-controlled (MTX), 3-month study with 4 doses of CH-4051 (0.3 mg, 1.0 mg, 3.0 mg and 3.0 mg with 1mg of folic acid supplementation p.o. daily) compared to a "standard" dose of MTX at 20 mg per week with 1 mg of folic acid supplementation p.o. daily. This study will be conducted in two parts:

Part A: Patients will be randomized to 0.3 mg CH-4051, 1.0 mg CH-4051 or MTX. Part B: Patients will not be randomized into Part B until the Data Monitoring Committee has reviewed safety data from the Part A when approximately 25 patients (10 patients in each CH-4051 dose groups and 5 patients in the MTX groups) have completed 3 months of treatment. At this time the DMC will make a recommendation whether or not to commence randomization to 3.0 mg CH-4051, 3.0 mg CH-4051 with 1.0 mg of folic acid.

Being tested
CH-4051, Methotrexate (MTX), Folic Acid
Keywords
rheumatoid arthritis, MTX, CH-405, antifolates
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • CH-4051Drug

    Different doses CH-4051 to be compared

  • Methotrexate (MTX)Drug

    Also called amethopterin

    20 mg MTX weekly

  • Folic AcidDrug

    Also called folate

    1 mg folic acid daily

Study groups in NCT01116141
Study groupRoleWhat they receive
Methotrexate (MTX) + Folic AcidActive comparator20 mg MTX weekly + 1 mg folic acid daily
Receives: Drug: Methotrexate (MTX); Drug: Folic Acid
0.3 mg CH-4051Experimental0.3 mg CH-4051 daily
Receives: Drug: CH-4051
1.0 mg CH-4051Experimental1.0 mg CH-4051 daily
Receives: Drug: CH-4051
3.0 mg CH-4051Experimental3.0 mg CH-4051 daily
Receives: Drug: CH-4051
3.0 mg CH-4051 + folic acidExperimental3.0 mg CH-4051 + 1.0 mg folic acid daily
Receives: Drug: CH-4051; Drug: Folic Acid

What is being measured

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

  1. Co-primary: Hybrid American College of Rheumatology response criteria (hACR)followed by the ACR20

    The hybrid ACR (hACR) response was developed by the American College of Rheumatology to provide an improvement measure more sensitive to change than many other currently used measures, e.g., traditional ACR 20, 50 and 70 responses, while still maintaining clinical meaning. While traditional ACR 20, 50 and 70 response criteria are dichotomous measures (responder = yes/no), the hACR is a semi-continuous variable based upon the traditional ACR response but incorporating additional information on patient response into the outcome measure.

    Measured: 12 weeks

Secondary outcomes (4)

  1. DAS28

    The disease activity score (DAS) is a combined index that was developed in Nijmegen in the 1980s to measure the disease activity in patients with RA. It has been extensively validated for its use in clinical trials in combination with the European League Against Rheumatism (EULAR) response criteria.

    Measured: 12 weeks

  2. ACR response criteria

    ACR assessment criteria is a widely accepted composite index of improvement in RA proposed by the American College of Rheumatology (ACR). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures: patient's own global assessment of RA disease activity; physician's global assessment of disease activity; patient's own assessment of pain due to RA; acute-phase reactant (erythrocyte sedimentation rate (ESR) or CRP); and patient's self-assessed disability (Health Assessment Questionnaire).

    Measured: 12 weeks

  3. Morning stiffness

    Morning stiffness is a common complaint of patients suffering from rheumatoid arthritis. Severity and joints involves varies from patient to patient. Patients will be asked, "Over the past 7 days, what has been the duration of stiffness of your joints in the morning?" The amount of time it takes a patient's morning stiffness to subside will be captured in hours and minutes.

    Measured: 12 weeks

  4. Safety and tolerability of CH-4051 in RA patients as determined by the frequency and severity of adverse events, laboratory abnormalities, and dropouts due to AEs

    Safety will be assessed by physical exams, vital signs, laboratory safety (blood and urine) and AEs. Liver functions tests will be identified as laboratory values of particular interest.

    Measured: 12 weeks

Timeline

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

  1. First posted4 May 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionApr 2012
  4. Study completionMay 2012

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116141
Sponsor's protocol ID
CH-4051-RA202
Acronym
MOTION
Status last verified
Apr 2013
First submitted
3 May 2010
Last updated
15 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CH-4051, Methotrexate (MTX) and Folic Acid in people with Rheumatoid Arthritis, run by Chelsea Therapeutics.

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 9 inclusion and 22 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 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Co-primary: Hybrid American College of Rheumatology response criteria (hACR)followed by the ACR20 (time frame: 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 NCT01116141.

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 Apr 2013.

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