Rheumatoid ArthritisPhase 3NCT00579644
Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
A Phase 3 study testing Combination of Minocycline and MTX or MTX alone and methotrexate in people with Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Combination of Minocycline and MTX or MTX alone and methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2001to 31 May 2006
- Phase
- Phase 3
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over or equal to 19 years old and less than or equal to 75 years old
- Diagnosis of RA as determined by fulfilling 4 of 7 ACR criteria
- Positive rheumatoid factor
- Duration of disease: greater than six weeks and less than one year
Who cannot join
- Allergy to tetracycline or methotrexate
- Previous DMARD treatment
- Doses of oral steroids greater than 7.5 mg/day
- Intra-articular injections within the last four weeks
- Significant liver or renal disease or active peptic ulcer disease
- Patients who are not willing to abstain from alcohol consumption
- Women of childbearing potential who are not practicing a successful method of contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis
Read the detailed description
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis (RA). Specific aims of this study are:
- To demonstrate that the combination of minocycline and methotrexate is well tolerated when used in the first year of RA.
- To compare the efficacy of the combination of minocycline and methotrexate with methotrexate and placebo therapy in early sero-positive RA patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Combination of Minocycline and MTX or MTX alone, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Minocycline and MTX or MTX aloneDrug
Also called Rheumatrex®, Trexall®, Dynacin®, Minocin®
Methotrexate Dosing:
1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.
3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.
4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg
methotrexateDrug
Also called Rheumatrex®, Trexall®
Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.
2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.
4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.
6, 8 and 10 month evaluations:
If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.
If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 12 month evaluation: End of the blinded portion of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 Methotrexate* & minocycline | Active comparator | Methotrexate Dosing:
1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.
3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.
4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg Receives: Drug: Combination of Minocycline and MTX or MTX alone |
| 2 Methotrexate | Active comparator | Methotrexate Dosing:
1. Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.
2. 2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.
3. 4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.
4. 6, 8 and 10 month evaluations:
* If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.
* If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month
5. 12 month evaluation: End of the blinded portion of the study. Receives: Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission evaluated by American College of Rheumatology (ACR) outcome variables
Patients will be evaluated and then at 2-month intervals to 12 months using the ACR core set of outcome variables (50) for remission. Additionally hand x-rays will be done.
Measured: 48 weeks
Secondary outcomes (1)
Comparison of combination therapy versus methotrexate alone, Composite Index
Clinically relevant comparison of the effectiveness of combination therapy versus methotrexate alone will be improvement by 20% and/or 70% by the American College of Rheumatology composite index.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start28 Mar 2001
- Primary completion31 May 2006
- Study completion31 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R O'Dell, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579644
- Sponsor's protocol ID
- 0519-00 FB
- Status last verified
- Oct 2023
- First submitted
- 18 Dec 2007
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
- ClinicalTrials.gov ID
- NCT00579644
- Acronym / sponsor ID
- 0519-00 FB
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 28 Mar 2001 (actual)
- Primary completion
- 31 May 2006 (actual)
- Study completion
- 31 May 2006 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
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 this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis
Detailed description
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis (RA). Specific aims of this study are:
- To demonstrate that the combination of minocycline and methotrexate is well tolerated when used in the first year of RA.
- To compare the efficacy of the combination of minocycline and methotrexate with methotrexate and placebo therapy in early sero-positive RA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Methotrexate* & minocycline | Active comparator | Drug: Combination of Minocycline and MTX or MTX aloneMethotrexate Dosing: 1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week. 3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week. 4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg |
| 2 Methotrexate | Active comparator | Drug: methotrexateMethotrexate Dosing: 1. Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week. 2. 2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week. 3. 4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week. 4. 6, 8 and 10 month evaluations: * If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week. * If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5. 12 month evaluation: End of the blinded portion of the study. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over or equal to 19 years old and less than or equal to 75 years old
- Diagnosis of RA as determined by fulfilling 4 of 7 ACR criteria
- Positive rheumatoid factor
- Duration of disease: greater than six weeks and less than one year
Key exclusion criteria (7 listed)
- Allergy to tetracycline or methotrexate
- Previous DMARD treatment
- Doses of oral steroids greater than 7.5 mg/day
- Intra-articular injections within the last four weeks
- Significant liver or renal disease or active peptic ulcer disease
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 |
|---|---|---|
| Combination of Minocycline and MTX or MTX aloneAlso: Rheumatrex®, Trexall®, Dynacin®, Minocin®Methotrexate Dosing: 1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week. 3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week. 4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg | Drug | 1 Methotrexate* & minocycline |
| methotrexateAlso: Rheumatrex®, Trexall®Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week. 2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week. 4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week. 6, 8 and 10 month evaluations: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 12 month evaluation: End of the blinded portion of the study. | Drug | 2 Methotrexate |
Primary outcome
Remission evaluated by American College of Rheumatology (ACR) outcome variables
Time frame: 48 weeks
Patients will be evaluated and then at 2-month intervals to 12 months using the ACR core set of outcome variables (50) for remission. Additionally hand x-rays will be done.
1 secondary outcome
Comparison of combination therapy versus methotrexate alone, Composite Index
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
James R O'Dell, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination of Minocycline and MTX or MTX alone and methotrexate in people with Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
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 4 inclusion and 7 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Remission evaluated by American College of Rheumatology (ACR) outcome variables (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.