Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) (OPERA)
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| ClinicalTrials.gov Identifier: NCT00660647 |
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Recruitment Status :
Completed
First Posted : April 17, 2008
Last Update Posted : November 24, 2015
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Optimized treatment algorithm in early rheumatoid arthritis:
Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis.
A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
Optimized Treatment Algorithms for Patients with Early RA
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arthritis, Rheumatoid | Drug: Adalimumab Drug: Placebo | Phase 3 |
In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patients into remission and cannot stop progressive, persistent joint damage. The possible benefits and risks of adding adalimumab to this conventional treatment algorithm is unknown.
The aim of the study is to clarify the possible benefits of adding adalimumab an anti-TNF-alfa inhibitor versus placebo to the treatment of rheumatoid arthritis patients, who are treated very early and given methotrexate and intraarticular triamcinolone hexacetonide. Efficacy will be evaluated by DAS 28, ACR 20/50/70, HAQ, progressive changes in X-ray, MRI and DXA-scans.
Adverse events will also be registered.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis |
| Study Start Date : | September 2007 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: methotrexate + adalimumab
Methotrexate and intraarticular triamcinolone hexacetonide plus adalimumab.
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Drug: Adalimumab
Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
Other Name: Humira |
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Placebo Comparator: methotrexate + placebo
Methotrexate and intraarticular triamcinolone hexacetonide and placebo
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Drug: Placebo
Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years
Other Name: Saline |
- Number of patients who achieve a DAS28 < 3.2 [ Time Frame: 0, 1, 3, 6, 9, 12 and 24 months (DAS28) ]
- Changes in DAS28 from start of treatment [ Time Frame: 1, 3, 6, 9, 12 and 24 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Patients (more than 18 years) with rheumatoid arthritis according to the ACR classification criteria (1) who have had the diagnose < 6 months.
2. Moderate to severe rheumatoid arthritis defined as DAS28 (CRP-based) > 3.2.
3. Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women are defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine.
4. Ability and willingness to inject the sc. injections him/herself or to have an assistant give the injections.
5. Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion Criteria:
1. Persons with latent TB defined with a positive Mantoux test (>12 mm for vaccinated and 6 mm for non-vaccinated), positive cultivation of mycobacteria in tissue samples, chest X-ray indicating TB,or other risk factors for activation of untreated latent TB, and persons not been given adequate TB prophylaxis according to the instructions of the department.
2. Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion
3. Positive serology for Hepatitis B or C indicating active infection.
4. Medical history with a positive HIV status (Check of HIV test upon suspicion).
5. Medical history with histoplasmosis or listeriosis.
6. Previous cancer or lymph proliferative disease except cases teated radically and have been without relapse for a minimum of 5 years.
Patients with previous squamous cell carcinoma, basal cell skin carcinoma or cervical dysplasia, who have been treated successfully and radically can be included.
7. Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, disturbed gait, facial paralysis, apraxia).
8. Severe renal insufficiency (creatinine clearance < 35 ml/min - nomogram).
9. Affected liver function: Liver enzymes > 2 x above normal limit value.
10. Clinical significant drug or alcohol abuse during the past year and/or current daily alcohol consumption.
11. Unstable diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcer or any other condition (e.g. kateter a demeure)which according to the investigator imposes an increased risk to the subject, if he/she participates in the protocol.
12. Anticoagulant therapy.
13. Pregnancy or breast-feeding.
14. Other inflammatory rheumatic diseases.
15. Aggressive parvovirus B19 infection.
16. Previous treatment with one or more DMARDs.
17. Glucocorticosteroid treatment within the last 4 weeks (except nasal and inhalation steroids).
18. Contraindications for trial medicine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660647
| Denmark | |
| Aarhus University Hospital | |
| Aarhus, Denmark, DK-8000 | |
| Principal Investigator: | Kristian Stengaard-Pedersen, Professor | Aarhus University/Aarhus University Hospital | |
| Principal Investigator: | Kim Hørslev-Petersen, Professor | King Christian X's Rheumatism Hospital, Graasten, Denmark |
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00660647 |
| Other Study ID Numbers: |
VEK-20070008 |
| First Posted: | April 17, 2008 Key Record Dates |
| Last Update Posted: | November 24, 2015 |
| Last Verified: | November 2015 |
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Rheumatoid arthritis, adalimumab, efficacy, adverse events |
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |